FDA product code JRW: Antisera, Fluorescent, B. Parapertussis
JRW is the FDA product code for antisera, fluorescent, b. parapertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under JRW, from 2 different applicants. The average 510(k) review took 10 days (median 10).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, B. Parapertussis |
| Device class | Class I |
| Regulation | 21 CFR 866.3065 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JRW clearance
Top JRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Royal Scientific, Inc. | 1 | 1978-05-12 |
| Beckman Instruments, Inc. | 1 | 1976-11-16 |
Most recent JRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780713 | Royal Scientific, Inc. | CULTURE SWAB | 1978-05-12 | 15 |
| K761019 | Beckman Instruments, Inc. | PIPETTER-DILUTER (MODEL 273) | 1976-11-16 | 5 |
Recalls for JRW devices
openFDA lists no recalls for product code JRW.
Frequently asked questions
What is FDA product code JRW?
JRW is the FDA product code for antisera, fluorescent, b. parapertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel.
What device class is JRW?
Class I, regulation 21 CFR 866.3065. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRW?
Across 2 cleared submissions the average was 10 days from receipt to decision (median 10).
Which companies have the most JRW clearances?
Royal Scientific, Inc. (1); Beckman Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRW
- Run a recall and safety report across every JRW manufacturer
- Watch product code JRW 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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