FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
5545–5568 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 17, 1984
HAEMOPHILUS I.D. II TRIPLATE
K840338 · JSI
Remel Co.
Microbiology · 83d
Cleared Apr 17, 1984
BIOTIS ABNORMAL CLINICAL CHEM SERUM-
K840458 · JJY
Otisville Biotech, Inc.
Microbiology · 75d
Cleared Apr 17, 1984
PORPHYRIN TEST AGAR
K840685 · JSF
Remel Co.
Microbiology · 62d
Cleared Apr 17, 1984
MULTIPLE BIOCHEMICAL TEST
K841204 · JSE
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & DIFFERENTIAL
K841206 · JSH
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & NON-DIFFERENTIAL
K841207 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
SELECTIVE AND DIFFERENTIAL
K841209 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
CAMPYLOBACTER THIOGLYCOLLATE MED
K841303 · JSG
Anaerobe Systems
Microbiology · 18d
Cleared Apr 17, 1984
HAEMOPHILUS ID QUAD-PLATE
K841304 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Apr 13, 1984
NORMAL CLINICAL CHEM. CONTROL SERUM-
K840457 · JJY
Otisville Biotech, Inc.
Microbiology · 71d
Cleared Apr 13, 1984
ISOSTAT MICROBIAL TUBE PROCESSING
K840496 · JKA
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 67d
Cleared Apr 13, 1984
HEMASTAPH
K840553 · JTL
Remel Co.
Microbiology · 65d
Cleared Apr 13, 1984
RIFAMPIN DISC
K840614 · JTO
Remel Co.
Microbiology · 60d
Cleared Apr 13, 1984
2U PENICILLIN DISC
K840686 · JTO
Remel Co.
Microbiology · 58d
Cleared Apr 13, 1984
COLISTIN DISC
K840708 · JTO
Remel Co.
Microbiology · 56d
Cleared Apr 13, 1984
CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP
K840969 · JTZ
Chatham Biological
Microbiology · 38d
Cleared Apr 13, 1984
CULTURE MEDIUM FOR PATHOGENIC NEISSER
K840970 · JTY
Chatham Biological
Microbiology · 38d
Cleared Apr 13, 1984
SELECTIVE CULTURE MEDIUM
K840971 · JSD
Chatham Biological
Microbiology · 38d
Cleared Apr 05, 1984
LEVINE EOSIN METHYLENE BLUE AGAR
K841142 · JSI
Anaerobe Systems
Microbiology · 20d
Cleared Apr 05, 1984
PROPAGATING TRANSPORT
K841208 · JSN
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
SELECTIVE BROTH
K841211 · JSD
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR
K841218 · JSI
Anaerobe Systems
Microbiology · 14d
Cleared Apr 04, 1984
DETECT GROUP A STREP TEST
K834582 · GTZ
Difco Laboratories, Inc.
Microbiology · 97d
Cleared Apr 04, 1984
HAEMOPHILUS INFLUENZAE TYPE B
K840506 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 58d