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
2305–2328 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 25, 1998
PREMIER GIARDIA
K982711 · MHI
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Nov 25, 1998
SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
K983259 · JWY
Ab Biodisk
Microbiology · 70d
Cleared Nov 25, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
K983301 · JWY
Accumed Intl., Inc.
Microbiology · 65d
Cleared Nov 25, 1998
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · GTY
Princeton BioMeditech Corp.
Microbiology · 60d
Cleared Nov 20, 1998
SYSTEM U3 FOR GENTAMICIN
K983252 · JWY
Ab Biodisk North America, Inc.
Microbiology · 65d
Cleared Nov 18, 1998
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
K981199 · LRG
Dade Microscan, Inc.
Microbiology · 230d
Cleared Nov 18, 1998
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
K982315 · LQP
Alexon - Trend, Inc.
Microbiology · 140d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · LYR
Abbott Laboratories
Microbiology · 135d
Cleared Nov 04, 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790 · LYR
Inova Diagnostics, Inc.
Microbiology · 86d
Cleared Oct 16, 1998
SERAQUEST RUBELLA IGM
K982281 · LFX
Quest Intl., Inc.
Microbiology · 108d
Cleared Oct 07, 1998
URISCREEN
K981084 · JXA
Diatech Diagnostics,Inc.
Microbiology · 196d
Cleared Oct 06, 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA,...
K982245 · MHI
Biosite Incorporated
Microbiology · 102d
Cleared Oct 02, 1998
TRIMETHOPRIM/SULPHAMETHOXAZOLE
K983027 · JWY
Ab Biodisk
Microbiology · 32d
Cleared Sep 30, 1998
ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE
K982868 · JWY
Ab Biodisk
Microbiology · 47d
Cleared Sep 29, 1998
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
K974901 · LJO
Digene Corp.
Microbiology · 272d
Cleared Sep 29, 1998
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · LGC
Diamedix Corp.
Microbiology · 172d
Cleared Sep 28, 1998
IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA...
K981226 · GQP
Dako Diagnostics , Ltd.
Microbiology · 188d
Cleared Sep 28, 1998
IS-VZU IGG TEST SYSTEM
K981867 · LFY
Diamedix Corp.
Microbiology · 123d
Cleared Sep 24, 1998
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
K974572 · MDK
Chugai Pharmaceuticals Co., Ltd.
Microbiology · 293d
Cleared Sep 22, 1998
IMMUNODOT MONO-G TEST
K974226 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
IMMUNODOT MONO-M TEST
K974244 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798 · LYR
Princeton BioMeditech Corp.
Microbiology · 204d
Cleared Sep 22, 1998
VTEC-RPLA SEIKEN
K981734 · GNA
Denka Seiken'S
Microbiology · 127d
Cleared Sep 21, 1998
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163 · LFZ
Diamedix Corp.
Microbiology · 174d