FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
GLE
Mixer, Blood Tube
1
Product Code
JBS
Timer, General Laboratory
1
Product Code
JJC
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
1
Product Code
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
1
Product Code
JJF
Analyzer, Chemistry, Micro, For Clinical Use
1
Product Code
JJG
Analyzer, Chemistry, Centrifugal, For Clinical Use
1
Product Code
JJH
Clinical Sample Concentrator
1
Product Code
JJI
Analyzer, Enzyme, For Clinical Use
1
Product Code
JJJ
Counter (Beta, Gamma) For Clinical Use
1
Product Code
JJK
Oncometer, Plasma, For Clinical Use
1
Product Code
JJL
Plasma Viscometer For Clinical Use
1
Product Code
JJM
Osmometer For Clinical Use
1
Product Code
JJN
Apparatus, Electrophoresis, For Clinical Use
1
Product Code
JJO
Flame Emission Photometer For Clinical Use
1
Product Code
JJP
Electrode, Ion Selective (Non-Specified)
1
Product Code
JJQ
Colorimeter, Photometer, Spectrophotometer For Clinical Use
1
Product Code
JQC
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
1
Product Code
JQO
Balance, Analytical
1
Product Code
JQP
Calculator/Data Processing Module, For Clinical Use
1
Product Code
JQQ
Dialyzer
1
Product Code
JQT
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
1
Product Code
JQW
Station, Pipetting And Diluting, For Clinical Use
1
Product Code
K
02
3955
BD VIPER INSTRUMENT
1
Cleared 510(K)
K
97
3335
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
1
Cleared 510(K)
K
98
0180
2700 SAMPLE MANAGER
1
Cleared 510(K)
K
97
0420
MASTERCAP AM 5.0/MASTERCAP RM 5.0
1
Cleared 510(K)
K
97
0616
MINI SAMPLER PROCESSOR
1
Cleared 510(K)
K
96
2687
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
1
Cleared 510(K)
K
96
2859
MINI SAMPLE PROCESSOR
1
Cleared 510(K)
K
96
1896
MICROLAB 4000, MICROLAB 4200
1
Cleared 510(K)
K
96
1694
IMPACT
1
Cleared 510(K)
K
95
3345
GENESIS
1
Cleared 510(K)
K
95
1753
MEDTEC AUTOBLOT 2000
1
Cleared 510(K)
K
95
2025
ROBOCAP
1
Cleared 510(K)
K
94
4556
4 CHANNEL DISPENSER
1
Cleared 510(K)
K
94
2655
4 CHANNEL DISPENSER
1
Cleared 510(K)
K
94
2290
STAR I WORKSTATION
1
Cleared 510(K)
K
94
1498
BIOMEK SL WITH BIOMEK SL INCUBATOR
1
Cleared 510(K)
K
94
1394
STAT FAX 2600
1
Cleared 510(K)
K
94
0390
IMPACT
1
Cleared 510(K)
K
93
6258
SYSTEM WASHER 100
1
Cleared 510(K)
K
93
4124
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
1
Cleared 510(K)
K
93
3088
PLATO 3000
1
Cleared 510(K)
K
92
5547
MAXSOFTWARE
1
Cleared 510(K)
K
92
3879
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
1
Cleared 510(K)
K
92
2803
WELLWASH 4 MARK II
1
Cleared 510(K)
K
92
2327
DENLEY WELLPREP 2 SAMPLE PROCESSOR
1
Cleared 510(K)
K
92
2183
WELLPREP 2000 SAMPLE PROCESSOR
1
Cleared 510(K)
K
92
3268
AFFIRM PROCESSOR
1
Cleared 510(K)
K
92
1005
AUTOLOADER
1
Cleared 510(K)
K
91
5492
RSP MEGA SAMPLE PROCESSOR
1
Cleared 510(K)
K
91
5284
STACKING MICROPLATE WASHER
1
Cleared 510(K)
K
91
3809
HY-PREP SYSTEM
1
Cleared 510(K)
K
91
3567
WELLPREP 1
1
Cleared 510(K)
K
91
3664
ROSYS MODELS 100 AND 200
1
Cleared 510(K)
K
91
2036
ROBOTIC SAMPLE PROCESSOR
1
Cleared 510(K)
K
91
2228
MARK 5 ROBOTIC PIPETTOR
1
Cleared 510(K)
K
91
1712
STRATUS(R) AUTOMATED SAMPLE HANDLER
1
Cleared 510(K)
K
91
0140
ELECTRAPETTE (R)
1
Cleared 510(K)
K
90
2592
EPC ELECTRONIC PIPETTING SYSTEM
1
Cleared 510(K)
K
90
0599
MICROPLATE REAGENT DISPENSER
1
Cleared 510(K)
K
89
6684
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
1
Cleared 510(K)
K
89
6631
EXEC-WASH SOLID PHASE WASHING SYSTEM
1
Cleared 510(K)
K
90
0775
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
1
Cleared 510(K)
K
89
7158
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
1
Cleared 510(K)
K
89
3811
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
1
Cleared 510(K)
K
89
4710
DPC-ROBOSTAT(TM)
1
Cleared 510(K)
K
89
4272
DENLEY WELLDILL 3
1
Cleared 510(K)
K
89
4069
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
1
Cleared 510(K)
K
89
4271
DENLEY WELLWASH 2 AND 4
1
Cleared 510(K)
K
89
4126
ROBOTIC SAMPLE PROCESSOR
1
Cleared 510(K)
K
89
3810
IMMUNO-WASH AUTOMATED TUBE WASHER
1
Cleared 510(K)
K
89
3775
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
1
Cleared 510(K)
K
89
3400
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)
1
Cleared 510(K)
K
89
3031
DELTA (TM) ROBOTIC PIPETTOR
1
Cleared 510(K)
K
89
0578
HI CHEM WASH CONCENTRATE REAGENT #88805
1
Cleared 510(K)
K
88
5340
AIR DISPLACEMENT PIPETTE
1
Cleared 510(K)
K
88
3470
IDS-1600 SAMPLE HANDLING SYSTEM
1
Cleared 510(K)
K
88
3749
PROBE(TM) MODELS 700 AND 1000
1
Cleared 510(K)
K
88
1195
DYNATECH SPD 2000, NUMBER 002-910-0000
1
Cleared 510(K)
K
87
3416
MULTI-ACCESS REAGENT DISPENSER
1
Cleared 510(K)
K
87
2363
DYNATECH SPD 3000, #002-900-0000
1
Cleared 510(K)
K
87
1687
TYTEM(R) REAGENT DISPENSER
1
Cleared 510(K)
K
87
0544
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION
1
Cleared 510(K)
K
87
0406
SMI DIGITRON
1
Cleared 510(K)
K
86
4875
ELECTRA AUTOMATIC SAMPLER
1
Cleared 510(K)
K
86
3887
SMI MULTIPETTOR(TM)
1
Cleared 510(K)
K
86
3624
ULTRAWASH II
1
Cleared 510(K)
K
86
3623
ULTRAWASH I
1
Cleared 510(K)
K
86
2701
SURESPOT
1
Cleared 510(K)
K
86
1580
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
1
Cleared 510(K)
K
86
1640
MODUMATIC (R) DILUTER
1
Cleared 510(K)
K
86
0508
POSID SAMPLER
1
Cleared 510(K)
K
85
4406
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
1
Cleared 510(K)
K
85
2285
DADE BLOOD GAS AMPUL INJECTOR
1
Cleared 510(K)
K
85
1403
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
1
Cleared 510(K)
K
85
0800
DROPSTIRS - PLASTIC DISPOSABLE PIPET
1
Cleared 510(K)
K
84
4798
EPPENDORF DILUTER
1
Cleared 510(K)
K
84
3779
AUTOLOADER II
1
Cleared 510(K)
K
84
3621
FIAX 420 DILUTOR
1
Cleared 510(K)
K
84
3607
LABOPETTOR
1
Cleared 510(K)
K
84
3606
PRECISION DISPENSER
1
Cleared 510(K)
K
84
2894
KEMBLE 405
1
Cleared 510(K)
K
84
3073
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP
1
Cleared 510(K)
K
84
2390
SYVA IQ 190 DIGITAL PIPETTER DILUTER
1
Cleared 510(K)
K
84
1043
BEHRING ELISA PROCESSOR M
1
Cleared 510(K)
K
84
0938
HIGH SPEED DISPENSER
1
Cleared 510(K)
K
83
4590
ACCUFLEX
1
Cleared 510(K)
K
83
3959
MICROLAB M DILUTER/DISPENSER
1
Cleared 510(K)
K
83
3666
UR/RITE SYSTEM
1
Cleared 510(K)
K
83
3505
IL MODEL 840 MICROPROCESSOR LOADER
1
Cleared 510(K)
K
83
2809
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
1
Cleared 510(K)
K
83
2205
PRECISION LIQUID DISPENSER
1
Cleared 510(K)
K
83
2204
MICROLAB P
1
Cleared 510(K)
K
83
2202
PB 600 REPEATING DISPENSER
1
Cleared 510(K)
K
83
1249
PRO QUANTUM
1
Cleared 510(K)
K
83
1273
QST TM SAMPLE PROCESSOR
1
Cleared 510(K)
K
83
0319
AUTO PREP
1
Cleared 510(K)
K
83
0157
DIGIFLEX AUTOMATIC PIPETTE
1
Cleared 510(K)
K
82
3364
COUNT-10 SYSTEM FOR STAND. URINALYSIS
1
Cleared 510(K)
K
82
2688
DIGITAL DILUTER/DISPENSERS
1
Cleared 510(K)
K
82
2208
CAVRO IQ-190 SAMPLE PROCESSOR
1
Cleared 510(K)
K
82
1034
SKATRON REPEATING DISPENSER
1
Cleared 510(K)
K
82
1039
UNI-PUMP 200
1
Cleared 510(K)
K
82
1007
ECLIPSE
1
Cleared 510(K)
K
81
3426
MULTIWASH
1
Cleared 510(K)
K
81
2983
DSD
1
Cleared 510(K)
K
81
2782
DISPENSER ASPIRATOR DA 300
1
Cleared 510(K)
K
81
2647
EMIT AUTO CAROUSEL
1
Cleared 510(K)
K
81
1696
IL #781, SEMI-AUTOMATED LOADER
1
Cleared 510(K)
K
81
1001
MICROERMA SYSTEM
1
Cleared 510(K)
K
81
0509
DIGITAL DISPENSING PUMP
1
Cleared 510(K)
K
80
3092
MIC-BIOPLATE INOCULATOR
1
Cleared 510(K)
K
80
2520
CENTRIFICHEM PIPETTOR ACCURACY CALIB.
1
Cleared 510(K)
K
80
1913
MICROLAB M-MICROPROCESSOR DILUTER/DISP
1
Cleared 510(K)
K
80
1851
CENTRIFICHEM PIPETTOR 1000
1
Cleared 510(K)
K
80
1271
MODEL 4900 OFF-LINE PREPARATION SYSTEM
1
Cleared 510(K)
K
80
1090
J.T. BAKER LSA 290 PIPETTER/DILUTER
1
Cleared 510(K)
K
80
1030
RIAUSE AUTO PROCESSOR
1
Cleared 510(K)
K
80
0606
MICROMEDIC AUTOMATIC DILUTER
1
Cleared 510(K)
K
80
0141
ACCUSTROKE PIPET
1
Cleared 510(K)
K
80
0075
MICROMEDIC PUNCH & ELUTER
1
Cleared 510(K)
K
79
1324
MICROMEDIC APS2
1
Cleared 510(K)
K
79
0041
ACCESSORY KIT, CENTRIFICHEM
1
Cleared 510(K)
K
78
2130
MINI-DILUTER 2
1
Cleared 510(K)
K
78
1883
DILUTER, LSA 290 PIPETTER
1
Cleared 510(K)
K
78
1645
AUTODILUTER 2
1
Cleared 510(K)
K
78
1646
SRD-2
1
Cleared 510(K)
K
78
0912
ADJUSTABLE DISPENSOR
1
Cleared 510(K)
K
78
0882
DILUTER/DISPENSER
1
Cleared 510(K)
K
78
0785
DILUTOR TRANSPORTER
1
Cleared 510(K)
K
78
0789
PERALISTIC PUMP MODEL 2000
1
Cleared 510(K)
K
78
0208
ASPIRATOR, MANUEL
1
Cleared 510(K)
K
77
0773
PIPETTE, DILUTING, MODEL ADP-30SD
1
Cleared 510(K)
K
77
0772
PIPETTE, DISPENSING, MODEL ADP-30SD
1
Cleared 510(K)
K
77
0307
MICRO/PETTOR, SMI
1
Cleared 510(K)
K
77
0355
PIPETTOR W/DETIPPER
1
Cleared 510(K)
K
77
0193
PIPETTOR, 400, CENTRIFICHEM SYSTEM
1
Cleared 510(K)
K
77
0208
MOTORIZED OPERATOR FOR PIPETTING DEV.
1
Cleared 510(K)
K
76
1290
COMPU-PET 300
1
Cleared 510(K)
K
77
0210
ANALYTIX AUTO SAMPLE PREP. STA. 1600
1
Cleared 510(K)
K
77
0013
PIPETTING DEVICES
1
Cleared 510(K)
JQX
Nephelometer, For Clinical Use
1
Product Code
JQY
Ph Meter
1
Product Code
JQZ
Polarimeter
1
Product Code
JRA
Microtitrator, For Clinical Use
1
Product Code
JRB
Micro Mixer
1
Product Code
JRC
Micro Pipette
1
Product Code
JRE
Refractometer For Clinical Use
1
Product Code
JRG
Block, Heating
1
Product Code
JRI
Cuvette, Thermostated
1
Product Code
JRJ
Unit, Drying
1
Product Code
JRK
Evaporator
1
Product Code
JRL
Unit, Filter, Membrane
1
Product Code
JRM
Freezer
1
Product Code
JRO
Blender/Mixer
1
Product Code
JRQ
Shaker/Stirrer
1
Product Code
JRR
Regulator, Temperature
1
Product Code
JRS
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
1
Product Code
KHO
Fluorometer, For Clinical Use
1
Product Code
KQO
Automated Urinalysis System
1
Product Code
LCI
Automated Radioimmunoassay Systems, For Clinical Use
1
Product Code
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
1
Product Code
NSU
Instrumentation For Clinical Multiplex Test Systems
2
Product Code
NVV
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
1
Product Code
OOI
Real Time Nucleic Acid Amplification System
2
Product Code
OTA
Mass Spectrometer For Clinical Multiplex Test Systems
2
Product Code
OUL
Thermocycler, Generic
1
Product Code
OVA
Complete Gene Expression Profiling Accessory Reagents
2
Product Code
PCA
Dna Genetic Analyzer
2
Product Code
PEG
Nucleic Acid Quantitation Kit
1
Product Code
PER
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
1
Product Code
PHG
Droplet Digital Pcr System
2
Product Code
PHV
Continuous Glucose Monitor Retrospective Data Analysis Software
1
Product Code
PSM
Refractometer For Donor Testing
1
Product Code
QBZ
Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
1
Product Code
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Dental
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Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
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 9 May 2025 at 11:05 pm
CH
/
subpart-c—clinical-laboratory-instruments
/
JQW
/
K811696
View Source
IL #781, SEMI-AUTOMATED LOADER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K811696
510(k) Type
Traditional
Applicant
INSTRUMENTATION LABORATORY CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/1/1981
Days to Decision
15 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
GLE
Mixer, Blood Tube
JBS
Timer, General Laboratory
JJC
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
JJF
Analyzer, Chemistry, Micro, For Clinical Use
JJG
Analyzer, Chemistry, Centrifugal, For Clinical Use
JJH
Clinical Sample Concentrator
JJI
Analyzer, Enzyme, For Clinical Use
JJJ
Counter (Beta, Gamma) For Clinical Use
JJK
Oncometer, Plasma, For Clinical Use
JJL
Plasma Viscometer For Clinical Use
JJM
Osmometer For Clinical Use
JJN
Apparatus, Electrophoresis, For Clinical Use
JJO
Flame Emission Photometer For Clinical Use
JJP
Electrode, Ion Selective (Non-Specified)
JJQ
Colorimeter, Photometer, Spectrophotometer For Clinical Use
JQC
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
JQO
Balance, Analytical
JQP
Calculator/Data Processing Module, For Clinical Use
JQQ
Dialyzer
JQT
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
JQW
Station, Pipetting And Diluting, For Clinical Use
K
02
3955
BD VIPER INSTRUMENT
K
97
3335
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
K
98
0180
2700 SAMPLE MANAGER
K
97
0420
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K
97
0616
MINI SAMPLER PROCESSOR
K
96
2687
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
K
96
2859
MINI SAMPLE PROCESSOR
K
96
1896
MICROLAB 4000, MICROLAB 4200
K
96
1694
IMPACT
K
95
3345
GENESIS
K
95
1753
MEDTEC AUTOBLOT 2000
K
95
2025
ROBOCAP
K
94
4556
4 CHANNEL DISPENSER
K
94
2655
4 CHANNEL DISPENSER
K
94
2290
STAR I WORKSTATION
K
94
1498
BIOMEK SL WITH BIOMEK SL INCUBATOR
K
94
1394
STAT FAX 2600
K
94
0390
IMPACT
K
93
6258
SYSTEM WASHER 100
K
93
4124
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
K
93
3088
PLATO 3000
K
92
5547
MAXSOFTWARE
K
92
3879
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
K
92
2803
WELLWASH 4 MARK II
K
92
2327
DENLEY WELLPREP 2 SAMPLE PROCESSOR
K
92
2183
WELLPREP 2000 SAMPLE PROCESSOR
K
92
3268
AFFIRM PROCESSOR
K
92
1005
AUTOLOADER
K
91
5492
RSP MEGA SAMPLE PROCESSOR
K
91
5284
STACKING MICROPLATE WASHER
K
91
3809
HY-PREP SYSTEM
K
91
3567
WELLPREP 1
K
91
3664
ROSYS MODELS 100 AND 200
K
91
2036
ROBOTIC SAMPLE PROCESSOR
K
91
2228
MARK 5 ROBOTIC PIPETTOR
K
91
1712
STRATUS(R) AUTOMATED SAMPLE HANDLER
K
91
0140
ELECTRAPETTE (R)
K
90
2592
EPC ELECTRONIC PIPETTING SYSTEM
K
90
0599
MICROPLATE REAGENT DISPENSER
K
89
6684
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
K
89
6631
EXEC-WASH SOLID PHASE WASHING SYSTEM
K
90
0775
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
K
89
7158
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K
89
3811
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
K
89
4710
DPC-ROBOSTAT(TM)
K
89
4272
DENLEY WELLDILL 3
K
89
4069
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K
89
4271
DENLEY WELLWASH 2 AND 4
K
89
4126
ROBOTIC SAMPLE PROCESSOR
K
89
3810
IMMUNO-WASH AUTOMATED TUBE WASHER
K
89
3775
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K
89
3400
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)
K
89
3031
DELTA (TM) ROBOTIC PIPETTOR
K
89
0578
HI CHEM WASH CONCENTRATE REAGENT #88805
K
88
5340
AIR DISPLACEMENT PIPETTE
K
88
3470
IDS-1600 SAMPLE HANDLING SYSTEM
K
88
3749
PROBE(TM) MODELS 700 AND 1000
K
88
1195
DYNATECH SPD 2000, NUMBER 002-910-0000
K
87
3416
MULTI-ACCESS REAGENT DISPENSER
K
87
2363
DYNATECH SPD 3000, #002-900-0000
K
87
1687
TYTEM(R) REAGENT DISPENSER
K
87
0544
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION
K
87
0406
SMI DIGITRON
K
86
4875
ELECTRA AUTOMATIC SAMPLER
K
86
3887
SMI MULTIPETTOR(TM)
K
86
3624
ULTRAWASH II
K
86
3623
ULTRAWASH I
K
86
2701
SURESPOT
K
86
1580
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
K
86
1640
MODUMATIC (R) DILUTER
K
86
0508
POSID SAMPLER
K
85
4406
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
K
85
2285
DADE BLOOD GAS AMPUL INJECTOR
K
85
1403
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K
85
0800
DROPSTIRS - PLASTIC DISPOSABLE PIPET
K
84
4798
EPPENDORF DILUTER
K
84
3779
AUTOLOADER II
K
84
3621
FIAX 420 DILUTOR
K
84
3607
LABOPETTOR
K
84
3606
PRECISION DISPENSER
K
84
2894
KEMBLE 405
K
84
3073
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP
K
84
2390
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K
84
1043
BEHRING ELISA PROCESSOR M
K
84
0938
HIGH SPEED DISPENSER
K
83
4590
ACCUFLEX
K
83
3959
MICROLAB M DILUTER/DISPENSER
K
83
3666
UR/RITE SYSTEM
K
83
3505
IL MODEL 840 MICROPROCESSOR LOADER
K
83
2809
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K
83
2205
PRECISION LIQUID DISPENSER
K
83
2204
MICROLAB P
K
83
2202
PB 600 REPEATING DISPENSER
K
83
1249
PRO QUANTUM
K
83
1273
QST TM SAMPLE PROCESSOR
K
83
0319
AUTO PREP
K
83
0157
DIGIFLEX AUTOMATIC PIPETTE
K
82
3364
COUNT-10 SYSTEM FOR STAND. URINALYSIS
K
82
2688
DIGITAL DILUTER/DISPENSERS
K
82
2208
CAVRO IQ-190 SAMPLE PROCESSOR
K
82
1034
SKATRON REPEATING DISPENSER
K
82
1039
UNI-PUMP 200
K
82
1007
ECLIPSE
K
81
3426
MULTIWASH
K
81
2983
DSD
K
81
2782
DISPENSER ASPIRATOR DA 300
K
81
2647
EMIT AUTO CAROUSEL
K
81
1696
IL #781, SEMI-AUTOMATED LOADER
K
81
1001
MICROERMA SYSTEM
K
81
0509
DIGITAL DISPENSING PUMP
K
80
3092
MIC-BIOPLATE INOCULATOR
K
80
2520
CENTRIFICHEM PIPETTOR ACCURACY CALIB.
K
80
1913
MICROLAB M-MICROPROCESSOR DILUTER/DISP
K
80
1851
CENTRIFICHEM PIPETTOR 1000
K
80
1271
MODEL 4900 OFF-LINE PREPARATION SYSTEM
K
80
1090
J.T. BAKER LSA 290 PIPETTER/DILUTER
K
80
1030
RIAUSE AUTO PROCESSOR
K
80
0606
MICROMEDIC AUTOMATIC DILUTER
K
80
0141
ACCUSTROKE PIPET
K
80
0075
MICROMEDIC PUNCH & ELUTER
K
79
1324
MICROMEDIC APS2
K
79
0041
ACCESSORY KIT, CENTRIFICHEM
K
78
2130
MINI-DILUTER 2
K
78
1883
DILUTER, LSA 290 PIPETTER
K
78
1645
AUTODILUTER 2
K
78
1646
SRD-2
K
78
0912
ADJUSTABLE DISPENSOR
K
78
0882
DILUTER/DISPENSER
K
78
0785
DILUTOR TRANSPORTER
K
78
0789
PERALISTIC PUMP MODEL 2000
K
78
0208
ASPIRATOR, MANUEL
K
77
0773
PIPETTE, DILUTING, MODEL ADP-30SD
K
77
0772
PIPETTE, DISPENSING, MODEL ADP-30SD
K
77
0307
MICRO/PETTOR, SMI
K
77
0355
PIPETTOR W/DETIPPER
K
77
0193
PIPETTOR, 400, CENTRIFICHEM SYSTEM
K
77
0208
MOTORIZED OPERATOR FOR PIPETTING DEV.
K
76
1290
COMPU-PET 300
K
77
0210
ANALYTIX AUTO SAMPLE PREP. STA. 1600
K
77
0013
PIPETTING DEVICES
JQX
Nephelometer, For Clinical Use
JQY
Ph Meter
JQZ
Polarimeter
JRA
Microtitrator, For Clinical Use
JRB
Micro Mixer
JRC
Micro Pipette
JRE
Refractometer For Clinical Use
JRG
Block, Heating
JRI
Cuvette, Thermostated
JRJ
Unit, Drying
JRK
Evaporator
JRL
Unit, Filter, Membrane
JRM
Freezer
JRO
Blender/Mixer
JRQ
Shaker/Stirrer
JRR
Regulator, Temperature
JRS
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
KHO
Fluorometer, For Clinical Use
KQO
Automated Urinalysis System
LCI
Automated Radioimmunoassay Systems, For Clinical Use
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
NSU
Instrumentation For Clinical Multiplex Test Systems
NVV
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
OOI
Real Time Nucleic Acid Amplification System
OTA
Mass Spectrometer For Clinical Multiplex Test Systems
OUL
Thermocycler, Generic
OVA
Complete Gene Expression Profiling Accessory Reagents
PCA
Dna Genetic Analyzer
PEG
Nucleic Acid Quantitation Kit
PER
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
PHG
Droplet Digital Pcr System
PHV
Continuous Glucose Monitor Retrospective Data Analysis Software
PSM
Refractometer For Donor Testing
QBZ
Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Serological Reagents
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CH
/
subpart-c—clinical-laboratory-instruments
/
JQW
/
K811696
View Source
IL #781, SEMI-AUTOMATED LOADER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K811696
510(k) Type
Traditional
Applicant
INSTRUMENTATION LABORATORY CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/1/1981
Days to Decision
15 days