Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- GKGCentrifuge, Hematocrit2Product Code
- GKMHand-Tally, Differential1Product Code
- GJGPipette, Quantitative, Hematology1Product Code
- GJWPipette, Pasteur1Product Code
- GKEOsmotic Fragility Testing1Product Code
- GGGGuaiac Reagent2Product Code
- GGXPipette, Sahli1Product Code
- GGYPipette, Diluting1Product Code
- GHCTube, Sedimentation Rate1Product Code
- GHOHemocytometer1Product Code
- GHYHematocrit, Tube, Rack, Sealer, Holder2Product Code
- GIOTube, Collection, Capillary Blood1Product Code
- GKWAggregometer, Platelet, Thrombokinetogram2Product Code
- GLGPlatelet Counting, Manual1Product Code
- JBXAggregrometer, Platelet2Product Code
- JBYAggregometer, Platelet, Photo-Optical Scanning2Product Code
- JBZStudy, Platelet Adhesive2Product Code
- JCADevice, Bleeding Time2Product Code
- JIOBlood, Occult, Colorimetric, In Urine2Product Code
- JIPBlood, Occult, Enzymatic Method, In Urine2Product Code
- JPHTest, Erythrocyte Sedimentation Rate1Product Code
- JPIDevice, Hematocrit Measuring2Product Code
- KHEReagent, Occult Blood2Product Code
- OOXAutomated Occult Blood Analyzer2Product Code
- OSLControl, Fecal Occult Blood2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Aggregometer, Platelet, Thrombokinetogram
- Page Type
- Product Code
- Regulation Medical Specialty
- Hematology
- Review Panel
- Hematology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.6675
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.6675 Platelet aggregometer
§ 864.6675 Platelet aggregometer.
(a) Identification. A platelet aggregometer is a device, used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet rich plasma.
(b) Classification. Class II (performance standards).
[45 FR 60608, Sept. 12, 1980]