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
2353–2376 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 30, 1998
PYLORIPROBE
K981396 · LYR
Amdl, Inc.
Microbiology · 104d
Cleared Jul 30, 1998
PASCO MIC AND MIC/ID PANELS
K982235 · JTN
Pasco Laboratories, Inc.
Microbiology · 35d
Cleared Jul 29, 1998
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156 · JWJ
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Jul 24, 1998
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
K981736 · MDB
Organon Teknika Corp.
Microbiology · 67d
Cleared Jul 22, 1998
VCA IGM ELISA TEST SYSTEM
K980596 · LSE
Clark Laboratories, Inc.
Microbiology · 155d
Cleared Jul 22, 1998
VCA IGG ELISA TEST SYSTEM
K980912 · LSE
Clark Laboratories, Inc.
Microbiology · 134d
Cleared Jul 17, 1998
COLORPAC TOXIN A
K980185 · LLH
Bd Becton Dickinson Vacutainer...
Microbiology · 178d
Cleared Jul 14, 1998
PAR-ONE
K981391 · LIO
Remel, Inc.
Microbiology · 88d
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · LJC
Dade Behring, Inc.
Microbiology · 16d
Cleared Jul 06, 1998
ADI SYPHILIS RPR LIQUID CONTROLS
K980638 · GMP
Ampcor Diagnostics, Inc.
Microbiology · 137d
Cleared Jul 06, 1998
ETEST CEFDINIR
K980877 · JWY
Ab Biodisk
Microbiology · 119d
Cleared Jun 15, 1998
ETEST BENZYLPENICILLIN
K980335 · JWY
Ab Biodisk
Microbiology · 138d
Cleared Jun 09, 1998
ETEST BENZYLPENICILLIN
K981135 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
ETEST FOSFOMYCIN
K981136 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
ETEST CEFOTAXIME
K981137 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
CEFDINIR, 5 UG, SENSI-DISC
K981517 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 42d
Cleared Jun 05, 1998
ETEST CIPROFLOXACIN
K981138 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
K971006 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
K971007 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
ETEST CEFTRIAXONE
K981139 · JWY
Ab Biodisk
Microbiology · 63d
Cleared May 29, 1998
ETEST CHLORAMPHENICAL
K980342 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 29, 1998
ETEST VANCOMYCIN
K980348 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 28, 1998
ETEST OFLOXACIN
K980338 · JWY
Ab Biodisk
Microbiology · 120d
Cleared May 28, 1998
ETEST TETRACYCLINE
K981134 · JWY
Ab Biodisk
Microbiology · 59d