FDA product code GJR: Control, Red-Cell
GJR is the FDA product code for control, red-cell. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under GJR, from 3 different applicants. The average 510(k) review took 104 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Control, Red-Cell |
| 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 GJR clearance
Top GJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck | 2 | 2008-02-05 |
| Streck Laboratories, Inc. | 2 | 2000-03-03 |
| Medical Specialties Intl., Inc. | 1 | 1995-02-06 |
Most recent GJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080016 | Streck | NRBC-CHEX FOR ADVIA | 2008-02-05 | 33 |
| K060083 | Streck | NRBC-CHEX FOR LH | 2006-02-09 | 29 |
| K000076 | Streck Laboratories, Inc. | CELL-CHEX | 2000-03-03 | 53 |
| K940430 | Medical Specialties Intl., Inc. | SEDRATROL | 1995-02-06 | 371 |
| K900484 | Streck Laboratories, Inc. | RET-CHECK | 1990-03-09 | 36 |
Recalls for GJR devices
openFDA lists no recalls for product code GJR.
Frequently asked questions
What is FDA product code GJR?
GJR is the FDA product code for control, red-cell. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GJR?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GJR?
Across 5 cleared submissions the average was 104 days from receipt to decision (median 36).
Which companies have the most GJR clearances?
Streck (2); Streck Laboratories, Inc. (2); Medical Specialties Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJR
- Run a recall and safety report across every GJR manufacturer
- Watch product code GJR 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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