FDA product code GRF: Antiserum, Cf, Rubeola
GRF is the FDA product code for antiserum, cf, rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GRF, from 2 different applicants. The average 510(k) review took 217 days (median 217).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, Rubeola |
| Device class | Class I |
| Regulation | 21 CFR 866.3520 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRF clearance
Top GRF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteo Technology, Inc. | 1 | 1993-04-08 |
| Microbix Biosystems, Inc. | 1 | 1985-11-12 |
Most recent GRF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922870 | Osteo Technology, Inc. | THREE SPIKE CUP | 1993-04-08 | 308 |
| K852932 | Microbix Biosystems, Inc. | MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT | 1985-11-12 | 126 |
Recalls for GRF devices
openFDA lists no recalls for product code GRF.
Frequently asked questions
What is FDA product code GRF?
GRF is the FDA product code for antiserum, cf, rubeola. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is GRF?
Class I, regulation 21 CFR 866.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRF?
Across 2 cleared submissions the average was 217 days from receipt to decision (median 217).
Which companies have the most GRF clearances?
Osteo Technology, Inc. (1); Microbix Biosystems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRF
- Run a recall and safety report across every GRF manufacturer
- Watch product code GRF 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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