GJP — Control, Platelet Class II
FDA product code GJP covers "Control, Platelet", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GJP
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K880608 | medical specialties | MSI-PC | March 21, 1988 |
| K823930 | fisher scientific co | HEMATOLOGY QUALITY CONTROL MIXTURE | February 1, 1983 |
| K771588 | dade, baxter travenol diagnostics | PLATELET CONTROLS NORMAL & ABNORMAL | August 25, 1977 |
| K770655 | bd becton dickinson vacutainer systems preanalytic | LATELET DETERMIBATION KIT, UL 800 | June 24, 1977 |