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
2713–2736 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 20, 1996
SAS SHIGELLA SONNEI GROUP D ANTISERUM
K961540 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM
K961541 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM
K961542 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
K961543 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM
K961546 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM
K961547 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM
K961548 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
K961549 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM
K961551 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM
K961553 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM
K961554 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
K961556 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
K961558 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
K961559 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 17, 1996
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
K961755 · JSN
Proteins Intl., Inc.
Microbiology · 11d
Cleared May 17, 1996
CYTOQUANT VIRAL TRANSPORT MEDIUM
K961756 · JSN
Proteins Intl., Inc.
Microbiology · 11d
Cleared May 14, 1996
TOXOSTAT
K944867 · LGD
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 595d
Cleared May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · LFX
Abbott Laboratories
Microbiology · 242d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · LSL
Abbott Laboratories
Microbiology · 881d
Cleared May 03, 1996
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682 · LSR
Genbio
Microbiology · 270d
Cleared May 03, 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683 · LSR
Genbio
Microbiology · 270d
Cleared Apr 29, 1996
EBNA IGG EIA TEST SYSTEM
K951549 · LLM
Immunoprobe, Inc.
Microbiology · 391d
Cleared Apr 26, 1996
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · JTW
Difco Laboratories, Inc.
Microbiology · 36d
Cleared Apr 18, 1996
IMMUNOCARD TOXIN A
K955859 · LLH
Meridian Diagnostics, Inc.
Microbiology · 113d