GWC — Antisera, All Types, Streptococcus Pneumoniae Class I
FDA Device Classification
Classification Details
- Product Code
- GWC
- Device Class
- Class I
- Regulation Number
- 866.3740
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K884966 | armkel | BACTIGEN(R) S. PNEUMONIAE | February 7, 1989 |
| K884965 | armkel | BACTIGEN(R) MENINGITIDIS PANEL | February 7, 1989 |
| K870029 | american micro scan | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | March 25, 1987 |
| K862848 | lkb instruments | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | December 18, 1986 |
| K842239 | ventrex laboratories | VENTRESCREEN STREP A TEST | July 2, 1984 |
| K841376 | wellcome diagnostics | WELLCOGEN S. PNEUMONIAE | May 2, 1984 |
| K831887 | armkel | BACTIGEN S. PNEUMONIAE | September 26, 1983 |
| K821960 | bd becton dickinson vacutainer systems preanalytic | BBL PNEUMOSLIDE TEST | July 30, 1982 |
| K802337 | pharmacia | PHADEBACT PNEUMOCOCCUS TEST | October 31, 1980 |