FDA product code GJP: Control, Platelet
GJP is the FDA product code for control, platelet. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under GJP, from 4 different applicants. The average 510(k) review took 40 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Control, Platelet |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GJP clearance
Top GJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Specialties, Inc. | 1 | 1988-03-21 |
| Fisher Scientific Co., LLC | 1 | 1983-02-01 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 1977-08-25 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1977-06-24 |
Most recent GJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880608 | Medical Specialties, Inc. | MSI-PC | 1988-03-21 | 38 |
| K823930 | Fisher Scientific Co., LLC | HEMATOLOGY QUALITY CONTROL MIXTURE | 1983-02-01 | 34 |
| K771588 | Dade, Baxter Travenol Diagnostics, Inc. | PLATELET CONTROLS NORMAL & ABNORMAL | 1977-08-25 | 7 |
| K770655 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LATELET DETERMIBATION KIT, UL 800 | 1977-06-24 | 79 |
Recalls for GJP devices
openFDA lists no recalls for product code GJP.
Frequently asked questions
What is FDA product code GJP?
GJP is the FDA product code for control, platelet. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GJP?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GJP?
Across 4 cleared submissions the average was 40 days from receipt to decision (median 36).
Which companies have the most GJP clearances?
Medical Specialties, Inc. (1); Fisher Scientific Co., LLC (1); Dade, Baxter Travenol Diagnostics, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJP
- Run a recall and safety report across every GJP manufacturer
- Watch product code GJP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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