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
2929–2952 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM
K953316 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM
K953317 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM
K953318 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM
K953319 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM
K953320 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM
K953321 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 1 ANTISERUM
K953322 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 2 ANTISERUM
K953323 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 3 ANTISERUN
K953324 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 4 ANTISERUM
K953325 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 5 ANTISERUM
K953326 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 6 ANTISERUM
K953327 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 7 ANTISERUM
K953328 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII GROUP C2 ANTISERUM
K953329 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 01, 1995
ZEUA MYCOPLASMA
K944417 · GRZ
Zeus Scientific, Inc.
Microbiology · 329d
Cleared Aug 01, 1995
IMX TOXO IGG
K951636 · LGD
Abbott Laboratories
Microbiology · 116d
Cleared Jul 25, 1995
SAS SALMONELLA H C ANTISERUM
K952288 · GRM
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 21, 1995
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
K946353 · LLM
Mrl Diagnostics
Microbiology · 203d
Cleared Jul 21, 1995
SAS BRUCELLA AMS ANTISERUM
K952132 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS SALMONELLA O POLY POSITIVE ANTISERUM
K952133 · GRM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS SALMONELLA H POLY POSITIVE ANTISERUM
K952134 · GRM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS FRANCISELLA TULARENSIS ANTISERUM
K952141 · GSK
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS BRUCELLA MELITENSIS ANTISERUM
K952143 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS BRUCELLA SUIS ANTISERUM
K952144 · GSM
Sa Scientific, Inc.
Microbiology · 74d