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Innolitics
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Review Panel
Cardiovascular
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Chemistry
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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
GKG
Centrifuge, Hematocrit
2
Product Code
GKM
Hand-Tally, Differential
1
Product Code
GJG
Pipette, Quantitative, Hematology
1
Product Code
GJW
Pipette, Pasteur
1
Product Code
GKE
Osmotic Fragility Testing
1
Product Code
GGG
Guaiac Reagent
2
Product Code
GGX
Pipette, Sahli
1
Product Code
GGY
Pipette, Diluting
1
Product Code
GHC
Tube, Sedimentation Rate
1
Product Code
GHO
Hemocytometer
1
Product Code
GHY
Hematocrit, Tube, Rack, Sealer, Holder
2
Product Code
GIO
Tube, Collection, Capillary Blood
1
Product Code
K
97
2969
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
1
Cleared 510(K)
K
94
1291
MONOJECT SAMPLETTE SEPARATOR TUBE
1
Cleared 510(K)
K
89
4851
TRU-TRAX
1
Cleared 510(K)
K
88
5324
HEMA(PRO)TEC(TION)
1
Cleared 510(K)
K
88
5138
CAPILLARY TUBE, BLOOD COLLECTION
1
Cleared 510(K)
K
88
4623
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
1
Cleared 510(K)
K
88
1262
CARAWAY TUBES, HEPARIN AND PLAIN
1
Cleared 510(K)
K
88
1187
NATELSON TUBES, HEPARIN AND PLAIN
1
Cleared 510(K)
K
87
5061
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
1
Cleared 510(K)
K
87
3647
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
1
Cleared 510(K)
K
85
0806
CORNING BLOOD COLLECTION CAPILLARY TUBES
1
Cleared 510(K)
K
84
3608
CAPILLARY BLOOD COLLECTION TUBE
1
Cleared 510(K)
K
84
3892
MICRO HEMATOCRIT CAPILLARY TUBES
1
Cleared 510(K)
K
84
3362
RINGCAPS
1
Cleared 510(K)
K
84
3361
MINICAPS
1
Cleared 510(K)
K
83
2578
MONOJET SAMPLETTE ADAPTERS
1
Cleared 510(K)
K
81
2969
S/P CAPILLARY TUBES, HEPARINIZED (2A)
1
Cleared 510(K)
K
81
2970
S/P CAPILLARY TUBES, HEPARINIZED (3A)
1
Cleared 510(K)
K
81
2921
S/P SURE-CAP
1
Cleared 510(K)
K
81
2922
S/P SURE-CAP C
1
Cleared 510(K)
K
81
2923
S/P SURE-CAP N
1
Cleared 510(K)
K
77
0981
LANCER CAPILLARY BLOOD SERUM SEPARATOR
1
Cleared 510(K)
GKW
Aggregometer, Platelet, Thrombokinetogram
2
Product Code
GLG
Platelet Counting, Manual
1
Product Code
JBX
Aggregrometer, Platelet
2
Product Code
JBY
Aggregometer, Platelet, Photo-Optical Scanning
2
Product Code
JBZ
Study, Platelet Adhesive
2
Product Code
JCA
Device, Bleeding Time
2
Product Code
JIO
Blood, Occult, Colorimetric, In Urine
2
Product Code
JIP
Blood, Occult, Enzymatic Method, In Urine
2
Product Code
JPH
Test, Erythrocyte Sedimentation Rate
1
Product Code
JPI
Device, Hematocrit Measuring
2
Product Code
KHE
Reagent, Occult Blood
2
Product Code
OOX
Automated Occult Blood Analyzer
2
Product Code
OSL
Control, Fecal Occult Blood
2
Product Code
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
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 16 May 2025 at 11:05 pm
HE
/
subpart-g—manual-hematology-devices
/
GIO
/
K843608
View Source
CAPILLARY BLOOD COLLECTION TUBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843608
510(k) Type
Traditional
Applicant
MEDICAL TECHNOMICS, LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/30/1984
Days to Decision
78 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
GKG
Centrifuge, Hematocrit
GKM
Hand-Tally, Differential
GJG
Pipette, Quantitative, Hematology
GJW
Pipette, Pasteur
GKE
Osmotic Fragility Testing
GGG
Guaiac Reagent
GGX
Pipette, Sahli
GGY
Pipette, Diluting
GHC
Tube, Sedimentation Rate
GHO
Hemocytometer
GHY
Hematocrit, Tube, Rack, Sealer, Holder
GIO
Tube, Collection, Capillary Blood
K
97
2969
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K
94
1291
MONOJECT SAMPLETTE SEPARATOR TUBE
K
89
4851
TRU-TRAX
K
88
5324
HEMA(PRO)TEC(TION)
K
88
5138
CAPILLARY TUBE, BLOOD COLLECTION
K
88
4623
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
K
88
1262
CARAWAY TUBES, HEPARIN AND PLAIN
K
88
1187
NATELSON TUBES, HEPARIN AND PLAIN
K
87
5061
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K
87
3647
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K
85
0806
CORNING BLOOD COLLECTION CAPILLARY TUBES
K
84
3608
CAPILLARY BLOOD COLLECTION TUBE
K
84
3892
MICRO HEMATOCRIT CAPILLARY TUBES
K
84
3362
RINGCAPS
K
84
3361
MINICAPS
K
83
2578
MONOJET SAMPLETTE ADAPTERS
K
81
2969
S/P CAPILLARY TUBES, HEPARINIZED (2A)
K
81
2970
S/P CAPILLARY TUBES, HEPARINIZED (3A)
K
81
2921
S/P SURE-CAP
K
81
2922
S/P SURE-CAP C
K
81
2923
S/P SURE-CAP N
K
77
0981
LANCER CAPILLARY BLOOD SERUM SEPARATOR
GKW
Aggregometer, Platelet, Thrombokinetogram
GLG
Platelet Counting, Manual
JBX
Aggregrometer, Platelet
JBY
Aggregometer, Platelet, Photo-Optical Scanning
JBZ
Study, Platelet Adhesive
JCA
Device, Bleeding Time
JIO
Blood, Occult, Colorimetric, In Urine
JIP
Blood, Occult, Enzymatic Method, In Urine
JPH
Test, Erythrocyte Sedimentation Rate
JPI
Device, Hematocrit Measuring
KHE
Reagent, Occult Blood
OOX
Automated Occult Blood Analyzer
OSL
Control, Fecal Occult Blood
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart I—Hematology Reagents
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-g—manual-hematology-devices
/
GIO
/
K843608
View Source
CAPILLARY BLOOD COLLECTION TUBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843608
510(k) Type
Traditional
Applicant
MEDICAL TECHNOMICS, LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/30/1984
Days to Decision
78 days