FDA product code GWB: Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
GWB is the FDA product code for antisera, fluorescent, all types, streptococcus pneumoniae. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GWB, from 2 different applicants. The average 510(k) review took 133 days (median 133).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Types, Streptococcus Pneumoniae |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GWB clearance
Top GWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 1 | 1993-03-23 |
| Aftercal, Inc. | 1 | 1976-10-29 |
Most recent GWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923555 | Codman & Shurtleff, Inc. | CODMAN GAAB NEUROENDOSCOPE | 1993-03-23 | 249 |
| K760816 | Aftercal, Inc. | PNEUMOTACHOGRAPHY SYSTEM | 1976-10-29 | 17 |
Recalls for GWB devices
openFDA lists no recalls for product code GWB.
Frequently asked questions
What is FDA product code GWB?
GWB is the FDA product code for antisera, fluorescent, all types, streptococcus pneumoniae. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is GWB?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWB?
Across 2 cleared submissions the average was 133 days from receipt to decision (median 133).
Which companies have the most GWB clearances?
Codman & Shurtleff, Inc. (1); Aftercal, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWB
- Run a recall and safety report across every GWB manufacturer
- Watch product code GWB 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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