Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
2329–2352 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027 · LFZ
DiaSorin, Inc.
Microbiology · 176d
Cleared Nov 25, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
EA-D IGM ELISA TEST SYSTEM
K982350 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
VCA IGM ELISA TEST SYSTEM
K982352 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
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