Control, Platelet
Control, Platelet (product code GJP) is a quality control material used to verify the accuracy and precision of platelet counting methods in automated hematology analyzers and manual counting procedures, supporting reliable clinical laboratory performance. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.8625 in the Hematology specialty (HE), this device carries no special regulatory flags.
Basic Information
- Product Code
- GJP
- Device Class
- FDA class 2
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent | MEDICAL SPECIALTIES, INC. |
| K823930 | HEMATOLOGY QUALITY CONTROL MIXTURE | Feb 01, 1983 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K771588 | PLATELET CONTROLS NORMAL & ABNORMAL | Aug 25, 1977 | Substantially Equivalent | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
| K770655 | LATELET DETERMIBATION KIT, UL 800 | Jun 24, 1977 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.