GWCClass I
Antisera, All Types, Streptococcus Pneumoniae
Microbiology · 21 CFR 866.3740
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances9All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Armkel, LLCFeb 7, 1989
K884966 · BACTIGEN(R) S. PNEUMONIAE
- Armkel, LLCFeb 7, 1989
K884965 · BACTIGEN(R) MENINGITIDIS PANEL
- American Micro ScanMar 25, 1987
K870029 · IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
- Lkb Instruments, Inc.Dec 18, 1986
K862848 · LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110
- Ventrex Laboratories, Inc.Jul 2, 1984
K842239 · VENTRESCREEN STREP A TEST
- Wellcome DiagnosticsMay 2, 1984
K841376 · WELLCOGEN S. PNEUMONIAE
- Armkel, LLCSep 26, 1983
K831887 · BACTIGEN S. PNEUMONIAE
- Bd Becton Dickinson Vacutainer Systems PreanalyticJul 30, 1982
K821960 · BBL PNEUMOSLIDE TEST