FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Manual Hematology Devices
CFR Sub-Part
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart I—Hematology Reagents
CFR Sub-Part
GIR
Reagent, Russel Viper Venom
1
Product Code
GJN
Fluid, Diluting, Red-Cell
1
Product Code
GJP
Control, Platelet
2
Product Code
GJR
Control, Red-Cell
2
Product Code
GFS
Standards And Controls, Hemoglobin, Normal And Abnormal
2
Product Code
GGJ
Fluid, Diluting, White-Cell
1
Product Code
GGK
Products, Red-Cell Lysing Products
1
Product Code
GGL
Control, White-Cell
2
Product Code
GGM
Control, Hemoglobin
2
Product Code
GIF
Diluent, Blood Cell
1
Product Code
GLK
Control, Hematocrit
2
Product Code
GLQ
Mixture, Control, White-Cell And Red-Cell Indices
2
Product Code
JCF
Lymphocyte Separation Medium
1
Product Code
JCG
Fluid, Diluting, Manual Cell
1
Product Code
JCN
Control, Cell Counter, Normal And Abnormal
2
Product Code
JCO
Bothrops Atrox Reagent
2
Product Code
JPK
Mixture, Hematology Quality Control
2
Product Code
K
16
0588
XN CHECK BF
2
Cleared 510(K)
K
16
0586
XN-L CHECK
2
Cleared 510(K)
K
16
0590
XN CHECK
2
Cleared 510(K)
K
16
0606
BC-5D Hematology Control
2
Cleared 510(K)
K
14
1957
XN CHECK BF
2
Cleared 510(K)
K
14
1964
XN CHECK
2
Cleared 510(K)
K
13
0962
R&D 5D RETIC HEMATOLOGY CONTROL
2
Cleared 510(K)
K
12
0742
XN CHECK
2
Cleared 510(K)
K
12
0744
XN CHECK BF
2
Cleared 510(K)
K
10
1578
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
2
Cleared 510(K)
K
10
0790
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
2
Cleared 510(K)
K
10
0607
COULTER 4C-EX 300 CELL CONTROL
2
Cleared 510(K)
K
09
1303
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
2
Cleared 510(K)
K
10
0050
R & D SYSTEMS XERET HEMATOLOGY CONTROL
2
Cleared 510(K)
K
09
1433
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
2
Cleared 510(K)
K
09
0201
UA-CELLULAR FOR IQ
2
Cleared 510(K)
K
08
2162
COULTER BODY FLUID CONTROL
2
Cleared 510(K)
K
08
1822
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
2
Cleared 510(K)
K
08
1641
COULTER LIN-X LINEARITY CONTROL
2
Cleared 510(K)
K
07
3178
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
2
Cleared 510(K)
K
07
2846
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
2
Cleared 510(K)
K
07
2268
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
2
Cleared 510(K)
K
07
2096
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
2
Cleared 510(K)
K
07
0199
RETIC-CHEX LINEARITY FOR BC
2
Cleared 510(K)
K
06
3218
E-CHECK (XE)
2
Cleared 510(K)
K
06
1511
R&D CBC-3D + CRP HEMATOLOGY CONTROL
2
Cleared 510(K)
K
06
1320
R&D LH-NRBC HEMATOLOGY CONTROL
2
Cleared 510(K)
K
06
1064
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
2
Cleared 510(K)
K
06
0464
COULTER 5C CELL CONTROL
2
Cleared 510(K)
K
05
3362
CELL-CHEX AUTO
2
Cleared 510(K)
K
05
1706
IQ BODY FLUIDS CONTROL
2
Cleared 510(K)
K
05
1339
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
2
Cleared 510(K)
K
05
0721
ABX ERYTROL
2
Cleared 510(K)
K
04
2836
LIQUICHEK RETICULOCYTE CONTROL (A)
2
Cleared 510(K)
K
04
2587
RETIC-CHEX FOR CELL-DYN
2
Cleared 510(K)
K
04
2336
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
2
Cleared 510(K)
K
04
2094
R&D CBC-XE HEMATOLOGY CONTROL
2
Cleared 510(K)
K
04
1457
LIQUICHEK HEMATOLOGY CONTROL (A)
2
Cleared 510(K)
K
02
4173
CDS 3-PD HEMATOLOGY CONTROLS
2
Cleared 510(K)
K
02
2968
ADVIA TESTPOINT CSF CONTROL
2
Cleared 510(K)
K
02
1922
MODIFICATION TO PARA 5X
2
Cleared 510(K)
K
02
0229
R & D BODY FLUID CONTROL
2
Cleared 510(K)
K
01
3898
R&D RET-LINE KIT
2
Cleared 510(K)
K
01
3842
IMMUNO-TROL LOW CELLS
2
Cleared 510(K)
K
01
1410
PARA 5X
2
Cleared 510(K)
K
01
0470
R & D 4K RETIC
2
Cleared 510(K)
K
01
0461
ADVIA RETIC PLUS
2
Cleared 510(K)
K
01
0598
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
2
Cleared 510(K)
K
01
0409
CBC-SF
2
Cleared 510(K)
K
01
0066
5C-ES CELL CONTROL, MODELS 7547191, 7547192
2
Cleared 510(K)
K
01
0064
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
2
Cleared 510(K)
K
00
3874
CBC-4K HEMATOLOGY CONTROL
2
Cleared 510(K)
K
00
3534
PENTRA 5D
2
Cleared 510(K)
K
00
3208
R & D 3K RETIC
2
Cleared 510(K)
K
00
2511
FETALTROL
2
Cleared 510(K)
K
00
0115
RETIC CHEX LINEARITY
2
Cleared 510(K)
K
99
3496
RETIC-QUINOX
2
Cleared 510(K)
K
99
1876
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
2
Cleared 510(K)
K
98
4216
IMMUNO-TROL CONTROL CELLS
2
Cleared 510(K)
K
98
3032
CBC-5D HEMATOLOGY CONTROL
2
Cleared 510(K)
K
98
4099
QBC CENTRIFUGAL HEMATOLOGY CONTROL
2
Cleared 510(K)
K
97
2170
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
2
Cleared 510(K)
K
97
2172
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
2
Cleared 510(K)
K
97
1469
COULTER ACT TRON CELL CONTROL
2
Cleared 510(K)
K
97
0331
CBC-4K HEMATOLOGY CONTROL
2
Cleared 510(K)
K
96
1673
R&D RETIC-PG HEMATOLOGY CONTROL
2
Cleared 510(K)
K
96
0557
CALIBRATION VERIFICATION ASSESSMENT (CVA)
2
Cleared 510(K)
K
96
0471
TRI-COUNT 20
2
Cleared 510(K)
K
96
0005
TRI-COURT 20-T
2
Cleared 510(K)
K
95
5334
COULTER LINEARITY CONTROL
2
Cleared 510(K)
K
95
5016
4C PLUS COULTER CELL CONTROL
2
Cleared 510(K)
K
95
4137
QBC CENTRIFUGAL HEMATOLOGY CONTROL
2
Cleared 510(K)
K
95
2720
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
2
Cleared 510(K)
K
95
2245
SF-CHECK
2
Cleared 510(K)
K
94
1965
EZ-RANGE
2
Cleared 510(K)
K
94
3336
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
2
Cleared 510(K)
K
94
3335
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
2
Cleared 510(K)
K
94
4751
COULTER FLOW SET
2
Cleared 510(K)
K
94
2822
CBC-LINE HEMATOLOGY LINEARITY CONTROL
2
Cleared 510(K)
K
93
5196
PARA 5 DIFF
2
Cleared 510(K)
K
94
0089
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
2
Cleared 510(K)
K
94
0181
SE-CHECK
2
Cleared 510(K)
K
93
5343
CENTRIFIQ BLOOD CONTROL
2
Cleared 510(K)
K
93
1947
CHECKPOINT
2
Cleared 510(K)
K
93
0119
COULTER RETIC-C CELL CONTROL
2
Cleared 510(K)
K
92
3971
QC-CHEX
2
Cleared 510(K)
K
91
4099
GAS TRAK CONNECT BLOOD GAS CONTROL
2
Cleared 510(K)
K
91
3879
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
2
Cleared 510(K)
K
91
2133
PX COULTER(R) CELL CONTROL
2
Cleared 510(K)
K
90
5524
RETIC-CHEX
2
Cleared 510(K)
K
90
4637
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
2
Cleared 510(K)
K
90
4461
METER TRAX
2
Cleared 510(K)
K
90
4464
CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
2
Cleared 510(K)
K
90
0017
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
2
Cleared 510(K)
K
89
3895
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
2
Cleared 510(K)
K
88
4266
PH BLOOD GAS CONTROL PRODUCTS
2
Cleared 510(K)
K
89
0767
NE-CHECK
2
Cleared 510(K)
K
89
0749
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
2
Cleared 510(K)
K
88
0270
MSI-DIFF PLUS
2
Cleared 510(K)
K
87
3354
QBC VENOUS BLOOD CONTROL/MULTIPLE
2
Cleared 510(K)
K
87
1067
MSI HEMATOLOGY CONTROL +
2
Cleared 510(K)
K
86
3224
HEMATALL-C PLUS HEMATOLOGY CONTROLS
2
Cleared 510(K)
K
86
2318
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
2
Cleared 510(K)
K
86
2186
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
2
Cleared 510(K)
K
86
0751
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
2
Cleared 510(K)
K
85
4353
PLATELET-TROL II
2
Cleared 510(K)
K
85
2992
PARA CHECK (AKA EIGHT CHECK-C)
2
Cleared 510(K)
K
85
3776
MSI-HB HEMOGLOBIN CONTROL
2
Cleared 510(K)
K
85
2372
CELL-DYN BRAND HEMATOLOGY REAGENTS
2
Cleared 510(K)
K
85
1663
QUICK-COUNT HEMATOLOGY CONTROLS
2
Cleared 510(K)
K
85
1375
TRI-COUNT
2
Cleared 510(K)
K
85
0755
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
2
Cleared 510(K)
K
85
0250
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
2
Cleared 510(K)
K
84
4928
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
2
Cleared 510(K)
K
84
4927
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
2
Cleared 510(K)
K
84
4897
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
2
Cleared 510(K)
K
84
3805
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
2
Cleared 510(K)
K
84
3485
TRI-COUNT LASER
2
Cleared 510(K)
K
84
1809
COUNT-A-PART PLUS
2
Cleared 510(K)
K
84
3962
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
2
Cleared 510(K)
K
84
3093
RETIC-CHEX
2
Cleared 510(K)
K
84
2286
DIA T1, T2 & T3
2
Cleared 510(K)
K
84
2440
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
2
Cleared 510(K)
K
84
2109
TECHNICON TEST POINT ASSAYED HEMATOLOGY
2
Cleared 510(K)
K
84
1531
PARA-TEK
2
Cleared 510(K)
K
84
2017
PARA 4
2
Cleared 510(K)
K
84
1239
ASSIGNED VALUE FOR MEAN PLATELET
2
Cleared 510(K)
K
84
0302
PLT - 4 PLATELET
2
Cleared 510(K)
K
83
4371
TRI-COUNT 10
2
Cleared 510(K)
K
83
4043
MSI-HC HEMATOLOGY CONTROL
2
Cleared 510(K)
K
83
3563
HC PLUS
2
Cleared 510(K)
K
83
3130
TRI-COUNT 7
2
Cleared 510(K)
K
83
1704
TECHNICON H6000 SYSTEM CONTROL
2
Cleared 510(K)
K
83
0864
WHITE BLOOD CELL CONTROL
2
Cleared 510(K)
K
83
1094
PARA LASAR
2
Cleared 510(K)
K
82
0731
HEMATALL-C PLUS HEMATOLOGY CONTROLS
2
Cleared 510(K)
K
82
0401
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
2
Cleared 510(K)
K
82
0400
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
2
Cleared 510(K)
K
81
2280
HEMATOLOGY CONTROL
2
Cleared 510(K)
K
81
2237
HEMOTOLOGY QUALITY CONTROL MIXTURE
2
Cleared 510(K)
K
81
2357
VENTREX DATA REDUCTION & QUAL. CONTR. SY
2
Cleared 510(K)
K
81
0756
HEMOTOLOGY QUALITY CONTROL MIXTURES
2
Cleared 510(K)
K
80
1054
THROMBO-TEST (X)
2
Cleared 510(K)
K
80
3083
ORTHO HEMOTOLOGY CONTROL-NORMAL
2
Cleared 510(K)
K
80
3084
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
2
Cleared 510(K)
K
80
3073
ORTHO HEMATOLOGY CONTROL
2
Cleared 510(K)
K
80
2267
PLT-4 SIZE-CHECK
2
Cleared 510(K)
K
80
2265
CBC PLT-4
2
Cleared 510(K)
K
80
2142
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
2
Cleared 510(K)
K
80
2143
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
2
Cleared 510(K)
K
80
2141
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
2
Cleared 510(K)
K
80
1265
WHITE BLOOD CELL COUNT CONTROL LEVELS
2
Cleared 510(K)
K
80
1267
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
2
Cleared 510(K)
K
80
0938
TRI-CHECK
2
Cleared 510(K)
K
80
0780
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
2
Cleared 510(K)
K
80
0361
HEMATO-CHEX
2
Cleared 510(K)
K
79
2606
WHOLE BLOOD PLATELET CONTROL NORMAL,
2
Cleared 510(K)
K
79
2467
PLATELET-CHEX FOR BLOOD CENTERS
2
Cleared 510(K)
K
79
2209
SANDARE HEMOGLOBIN CONTROLS
2
Cleared 510(K)
K
79
2055
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
2
Cleared 510(K)
K
79
1772
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
2
Cleared 510(K)
K
79
1750
COUNTER-CHECK PLUS
2
Cleared 510(K)
K
79
1228
PARA-8
2
Cleared 510(K)
K
79
1227
PARA-7
2
Cleared 510(K)
K
79
1226
PLATELET-CHEX PLUS
2
Cleared 510(K)
K
79
1030
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
2
Cleared 510(K)
K
79
0826
COAGULATION ARP
2
Cleared 510(K)
K
79
0457
HEMOGLOBIN CONTROLS
2
Cleared 510(K)
K
79
0415
HCP-7
2
Cleared 510(K)
K
79
0525
HEMATROL S HEMATOLOGY CONTROLS
2
Cleared 510(K)
K
78
1969
BLOOD, HEMATOLOGY REFERENCE CONTROL
2
Cleared 510(K)
K
78
1745
QUANTICEL HHR, L531 AND L532
2
Cleared 510(K)
K
78
1786
QUANTICEL HHR # L500 AND L501
2
Cleared 510(K)
K
78
1573
ABNORMAL HEMATOLOGY CONTROL UNASSAYED
2
Cleared 510(K)
K
78
1572
NORMAL HEMATOLOGY CONTROL UNASSAYED
2
Cleared 510(K)
K
78
1247
QUANTICEL-HRP
2
Cleared 510(K)
K
78
1077
CONTROL, HEMATOLOGY, CH-60
2
Cleared 510(K)
K
78
0980
PLATELET CONTROL
2
Cleared 510(K)
K
78
0835
ARANTROL
2
Cleared 510(K)
K
78
0714
PLATELET CONTROL
2
Cleared 510(K)
K
78
0140
CELL-CHEX
2
Cleared 510(K)
K
77
2195
HEMATOLOGY REFERENCE CONTROLS
2
Cleared 510(K)
K
77
1753
HEMATOLOGY REFERENCE CONTROL
2
Cleared 510(K)
K
77
0384
MNITROL HEMOTOL. REF. AND CONTROL
2
Cleared 510(K)
K
77
0386
LATELET, CONTROL, NORMAL & ABNORMAL
2
Cleared 510(K)
K
77
0095
PLATELET CONTROL, NORMAL & ABNORMAL
2
Cleared 510(K)
K
77
0020
PLATELET-CHEX-HUMAN
2
Cleared 510(K)
K
76
0682
4C ABNORMAL LOW-HIGH (8 X 6 M1)
2
Cleared 510(K)
K
76
0597
BIOTROL-NORMAL
2
Cleared 510(K)
K
76
0596
BIOTROL-ABNORMAL
2
Cleared 510(K)
K
76
0549
PLATELET CONTROLS, NORMAL & ABNORMAL
2
Cleared 510(K)
K
76
0162
HEMATOLOGY CONTROL
2
Cleared 510(K)
KRX
Calibrator For Cell Indices
2
Product Code
KRY
Calibrator For Platelet Counting
2
Product Code
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
2
Product Code
KSA
Calibrator For Red-Cell And White-Cell Counting
2
Product Code
MZG
Test, Residual, Wbc In Leukoreduced Blood
2
Product Code
NRF
Material, Quality Control, Semen Analysis
2
Product Code
NRS
Control Material, Blood Circulating Epithelial Cancer Cell
2
Product Code
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
CFR Sub-Part
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
CFR Sub-Part
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 23 May 2025 at 11:06 pm
HE
/
subpart-i—hematology-reagents
/
JPK
/
K791226
View Source
PLATELET-CHEX PLUS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K791226
510(k) Type
Traditional
Applicant
STRECK LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/1979
Days to Decision
32 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Diagnostic Devices
Subpart C—Cell And Tissue Culture Products
Subpart C—Clinical Laboratory Instruments
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Subpart G—Manual Hematology Devices
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart I—Hematology Reagents
GIR
Reagent, Russel Viper Venom
GJN
Fluid, Diluting, Red-Cell
GJP
Control, Platelet
GJR
Control, Red-Cell
GFS
Standards And Controls, Hemoglobin, Normal And Abnormal
GGJ
Fluid, Diluting, White-Cell
GGK
Products, Red-Cell Lysing Products
GGL
Control, White-Cell
GGM
Control, Hemoglobin
GIF
Diluent, Blood Cell
GLK
Control, Hematocrit
GLQ
Mixture, Control, White-Cell And Red-Cell Indices
JCF
Lymphocyte Separation Medium
JCG
Fluid, Diluting, Manual Cell
JCN
Control, Cell Counter, Normal And Abnormal
JCO
Bothrops Atrox Reagent
JPK
Mixture, Hematology Quality Control
K
16
0588
XN CHECK BF
K
16
0586
XN-L CHECK
K
16
0590
XN CHECK
K
16
0606
BC-5D Hematology Control
K
14
1957
XN CHECK BF
K
14
1964
XN CHECK
K
13
0962
R&D 5D RETIC HEMATOLOGY CONTROL
K
12
0742
XN CHECK
K
12
0744
XN CHECK BF
K
10
1578
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
K
10
0790
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
K
10
0607
COULTER 4C-EX 300 CELL CONTROL
K
09
1303
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
K
10
0050
R & D SYSTEMS XERET HEMATOLOGY CONTROL
K
09
1433
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
K
09
0201
UA-CELLULAR FOR IQ
K
08
2162
COULTER BODY FLUID CONTROL
K
08
1822
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
K
08
1641
COULTER LIN-X LINEARITY CONTROL
K
07
3178
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K
07
2846
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K
07
2268
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K
07
2096
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K
07
0199
RETIC-CHEX LINEARITY FOR BC
K
06
3218
E-CHECK (XE)
K
06
1511
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K
06
1320
R&D LH-NRBC HEMATOLOGY CONTROL
K
06
1064
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
K
06
0464
COULTER 5C CELL CONTROL
K
05
3362
CELL-CHEX AUTO
K
05
1706
IQ BODY FLUIDS CONTROL
K
05
1339
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K
05
0721
ABX ERYTROL
K
04
2836
LIQUICHEK RETICULOCYTE CONTROL (A)
K
04
2587
RETIC-CHEX FOR CELL-DYN
K
04
2336
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K
04
2094
R&D CBC-XE HEMATOLOGY CONTROL
K
04
1457
LIQUICHEK HEMATOLOGY CONTROL (A)
K
02
4173
CDS 3-PD HEMATOLOGY CONTROLS
K
02
2968
ADVIA TESTPOINT CSF CONTROL
K
02
1922
MODIFICATION TO PARA 5X
K
02
0229
R & D BODY FLUID CONTROL
K
01
3898
R&D RET-LINE KIT
K
01
3842
IMMUNO-TROL LOW CELLS
K
01
1410
PARA 5X
K
01
0470
R & D 4K RETIC
K
01
0461
ADVIA RETIC PLUS
K
01
0598
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K
01
0409
CBC-SF
K
01
0066
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K
01
0064
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K
00
3874
CBC-4K HEMATOLOGY CONTROL
K
00
3534
PENTRA 5D
K
00
3208
R & D 3K RETIC
K
00
2511
FETALTROL
K
00
0115
RETIC CHEX LINEARITY
K
99
3496
RETIC-QUINOX
K
99
1876
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K
98
4216
IMMUNO-TROL CONTROL CELLS
K
98
3032
CBC-5D HEMATOLOGY CONTROL
K
98
4099
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K
97
2170
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K
97
2172
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K
97
1469
COULTER ACT TRON CELL CONTROL
K
97
0331
CBC-4K HEMATOLOGY CONTROL
K
96
1673
R&D RETIC-PG HEMATOLOGY CONTROL
K
96
0557
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K
96
0471
TRI-COUNT 20
K
96
0005
TRI-COURT 20-T
K
95
5334
COULTER LINEARITY CONTROL
K
95
5016
4C PLUS COULTER CELL CONTROL
K
95
4137
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K
95
2720
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K
95
2245
SF-CHECK
K
94
1965
EZ-RANGE
K
94
3336
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
K
94
3335
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K
94
4751
COULTER FLOW SET
K
94
2822
CBC-LINE HEMATOLOGY LINEARITY CONTROL
K
93
5196
PARA 5 DIFF
K
94
0089
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
K
94
0181
SE-CHECK
K
93
5343
CENTRIFIQ BLOOD CONTROL
K
93
1947
CHECKPOINT
K
93
0119
COULTER RETIC-C CELL CONTROL
K
92
3971
QC-CHEX
K
91
4099
GAS TRAK CONNECT BLOOD GAS CONTROL
K
91
3879
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K
91
2133
PX COULTER(R) CELL CONTROL
K
90
5524
RETIC-CHEX
K
90
4637
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
K
90
4461
METER TRAX
K
90
4464
CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
K
90
0017
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
K
89
3895
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
K
88
4266
PH BLOOD GAS CONTROL PRODUCTS
K
89
0767
NE-CHECK
K
89
0749
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K
88
0270
MSI-DIFF PLUS
K
87
3354
QBC VENOUS BLOOD CONTROL/MULTIPLE
K
87
1067
MSI HEMATOLOGY CONTROL +
K
86
3224
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K
86
2318
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
K
86
2186
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
K
86
0751
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K
85
4353
PLATELET-TROL II
K
85
2992
PARA CHECK (AKA EIGHT CHECK-C)
K
85
3776
MSI-HB HEMOGLOBIN CONTROL
K
85
2372
CELL-DYN BRAND HEMATOLOGY REAGENTS
K
85
1663
QUICK-COUNT HEMATOLOGY CONTROLS
K
85
1375
TRI-COUNT
K
85
0755
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K
85
0250
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K
84
4928
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
K
84
4927
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
K
84
4897
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
K
84
3805
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K
84
3485
TRI-COUNT LASER
K
84
1809
COUNT-A-PART PLUS
K
84
3962
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K
84
3093
RETIC-CHEX
K
84
2286
DIA T1, T2 & T3
K
84
2440
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
K
84
2109
TECHNICON TEST POINT ASSAYED HEMATOLOGY
K
84
1531
PARA-TEK
K
84
2017
PARA 4
K
84
1239
ASSIGNED VALUE FOR MEAN PLATELET
K
84
0302
PLT - 4 PLATELET
K
83
4371
TRI-COUNT 10
K
83
4043
MSI-HC HEMATOLOGY CONTROL
K
83
3563
HC PLUS
K
83
3130
TRI-COUNT 7
K
83
1704
TECHNICON H6000 SYSTEM CONTROL
K
83
0864
WHITE BLOOD CELL CONTROL
K
83
1094
PARA LASAR
K
82
0731
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K
82
0401
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
K
82
0400
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
K
81
2280
HEMATOLOGY CONTROL
K
81
2237
HEMOTOLOGY QUALITY CONTROL MIXTURE
K
81
2357
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K
81
0756
HEMOTOLOGY QUALITY CONTROL MIXTURES
K
80
1054
THROMBO-TEST (X)
K
80
3083
ORTHO HEMOTOLOGY CONTROL-NORMAL
K
80
3084
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
K
80
3073
ORTHO HEMATOLOGY CONTROL
K
80
2267
PLT-4 SIZE-CHECK
K
80
2265
CBC PLT-4
K
80
2142
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K
80
2143
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K
80
2141
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K
80
1265
WHITE BLOOD CELL COUNT CONTROL LEVELS
K
80
1267
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
K
80
0938
TRI-CHECK
K
80
0780
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
K
80
0361
HEMATO-CHEX
K
79
2606
WHOLE BLOOD PLATELET CONTROL NORMAL,
K
79
2467
PLATELET-CHEX FOR BLOOD CENTERS
K
79
2209
SANDARE HEMOGLOBIN CONTROLS
K
79
2055
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
K
79
1772
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
K
79
1750
COUNTER-CHECK PLUS
K
79
1228
PARA-8
K
79
1227
PARA-7
K
79
1226
PLATELET-CHEX PLUS
K
79
1030
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
K
79
0826
COAGULATION ARP
K
79
0457
HEMOGLOBIN CONTROLS
K
79
0415
HCP-7
K
79
0525
HEMATROL S HEMATOLOGY CONTROLS
K
78
1969
BLOOD, HEMATOLOGY REFERENCE CONTROL
K
78
1745
QUANTICEL HHR, L531 AND L532
K
78
1786
QUANTICEL HHR # L500 AND L501
K
78
1573
ABNORMAL HEMATOLOGY CONTROL UNASSAYED
K
78
1572
NORMAL HEMATOLOGY CONTROL UNASSAYED
K
78
1247
QUANTICEL-HRP
K
78
1077
CONTROL, HEMATOLOGY, CH-60
K
78
0980
PLATELET CONTROL
K
78
0835
ARANTROL
K
78
0714
PLATELET CONTROL
K
78
0140
CELL-CHEX
K
77
2195
HEMATOLOGY REFERENCE CONTROLS
K
77
1753
HEMATOLOGY REFERENCE CONTROL
K
77
0384
MNITROL HEMOTOL. REF. AND CONTROL
K
77
0386
LATELET, CONTROL, NORMAL & ABNORMAL
K
77
0095
PLATELET CONTROL, NORMAL & ABNORMAL
K
77
0020
PLATELET-CHEX-HUMAN
K
76
0682
4C ABNORMAL LOW-HIGH (8 X 6 M1)
K
76
0597
BIOTROL-NORMAL
K
76
0596
BIOTROL-ABNORMAL
K
76
0549
PLATELET CONTROLS, NORMAL & ABNORMAL
K
76
0162
HEMATOLOGY CONTROL
KRX
Calibrator For Cell Indices
KRY
Calibrator For Platelet Counting
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
KSA
Calibrator For Red-Cell And White-Cell Counting
MZG
Test, Residual, Wbc In Leukoreduced Blood
NRF
Material, Quality Control, Semen Analysis
NRS
Control Material, Blood Circulating Epithelial Cancer Cell
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HE
/
subpart-i—hematology-reagents
/
JPK
/
K791226
View Source
PLATELET-CHEX PLUS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K791226
510(k) Type
Traditional
Applicant
STRECK LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/1979
Days to Decision
32 days