GWC
9 FDA 510(k) clearances · Product code
69 daysmedian time to decision
142 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antisera, All Types, Streptococcus Pneumoniae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BACTIGEN(R) S. PNEUMONIAE (K884966) | Armkel, LLC | 1989-02-07 |
| BACTIGEN(R) MENINGITIDIS PANEL (K884965) | Armkel, LLC | 1989-02-07 |
| IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (K870029) | American Micro Scan | 1987-03-25 |
| LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (K862848) | Lkb Instruments, Inc. | 1986-12-18 |
| VENTRESCREEN STREP A TEST (K842239) | Ventrex Laboratories, Inc. | 1984-07-02 |
| WELLCOGEN S. PNEUMONIAE (K841376) | Wellcome Diagnostics | 1984-05-02 |
| BACTIGEN S. PNEUMONIAE (K831887) | Armkel, LLC | 1983-09-26 |
| BBL PNEUMOSLIDE TEST (K821960) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-07-30 |
| PHADEBACT PNEUMOCOCCUS TEST (K802337) | Pharmacia, Inc. | 1980-10-31 |
Track GWC automatically
Every clearance here is in the API, with alerts when new ones post.