FDA product code GWC: Antisera, All Types, Streptococcus Pneumoniae
GWC is the FDA product code for antisera, 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 9 510(k) submissions under GWC, from 7 different applicants. The average 510(k) review took 65 days (median 69).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, 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 GWC clearance
Top GWC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Armkel, LLC | 3 | 1989-02-07 |
| American Micro Scan | 1 | 1987-03-25 |
| Lkb Instruments, Inc. | 1 | 1986-12-18 |
| Ventrex Laboratories, Inc. | 1 | 1984-07-02 |
| Wellcome Diagnostics | 1 | 1984-05-02 |
2 more applicants have GWC clearances. See the full list in Caduvo.
Most recent GWC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884965 | Armkel, LLC | BACTIGEN(R) MENINGITIDIS PANEL | 1989-02-07 | 69 |
| K884966 | Armkel, LLC | BACTIGEN(R) S. PNEUMONIAE | 1989-02-07 | 69 |
| K870029 | American Micro Scan | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | 1987-03-25 | 79 |
| K862848 | Lkb Instruments, Inc. | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | 1986-12-18 | 142 |
| K842239 | Ventrex Laboratories, Inc. | VENTRESCREEN STREP A TEST | 1984-07-02 | 27 |
Recalls for GWC devices
openFDA lists no recalls for product code GWC.
Frequently asked questions
What is FDA product code GWC?
GWC is the FDA product code for antisera, 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 GWC?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWC?
Across 9 cleared submissions the average was 65 days from receipt to decision (median 69).
Which companies have the most GWC clearances?
Armkel, LLC (3); American Micro Scan (1); Lkb Instruments, Inc. (1); Ventrex Laboratories, Inc. (1); Wellcome Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWC
- Run a recall and safety report across every GWC manufacturer
- Watch product code GWC 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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