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
3577–3600 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 26, 1991
M. CAT. BUTYRATE DISC
K905666 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 70d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · LGD
Abbott Laboratories
Microbiology · 27d
Cleared Feb 25, 1991
ANTIMICROBIAL CEFOPERAZONE
K910345 · JWY
Alamar
Microbiology · 28d
Cleared Feb 25, 1991
ANTIMICROBIAL CEFTRIAXONE
K910346 · JWY
Alamar
Microbiology · 28d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042 · LJN
Gull Laboratories, Inc.
Microbiology · 48d
Cleared Feb 20, 1991
NITRATE DISK
K905163 · JTO
Remel Co.
Microbiology · 96d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS
K904689 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 120d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K905853 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 51d
Cleared Feb 01, 1991
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
K904095 · GQL
California Integrated Diagnostics, Inc.
Microbiology · 148d
Cleared Jan 30, 1991
MERISTAR-MP
K905493 · GSA
Meridian Diagnostics, Inc.
Microbiology · 54d
Cleared Jan 28, 1991
RAPITEX(R) ASL NEW
K903854 · GTQ
Behring Diagnostics, Inc.
Microbiology · 160d
Cleared Jan 28, 1991
DYNATECH MR4000 MICROPLATE READER
K904567 · JJQ
Dynatech Corp.
Microbiology · 111d
Cleared Jan 28, 1991
SLIDEX STREPTO-KIT
K905020 · GTY
Vitek Systems, Inc.
Microbiology · 82d
Cleared Jan 25, 1991
RHEUMAGEN ASO T-CONTROL
K904311 · GTQ
Biokit USA, Inc.
Microbiology · 128d
Cleared Jan 25, 1991
PREMIER-CRYPTOCOCCAL ANTIGEN
K904393 · MDU
Meridian Diagnostics, Inc.
Microbiology · 122d
Cleared Jan 25, 1991
VANCOMYCIN DISK-5 MCG
K905151 · JTO
Remel Co.
Microbiology · 71d
Cleared Jan 24, 1991
E. COLI 0157 LATEX TEST
K903714 · GNA
Pro-Lab, Inc.
Microbiology · 163d
Cleared Jan 18, 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · LIO
Medical Laboratory Automation...
Microbiology · 158d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · GTY
Eastman Kodak Company
Microbiology · 101d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 89d
Cleared Jan 08, 1991
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 454d
Cleared Jan 03, 1991
RUBEOLA IGM ELISA TEST
K904083 · LJB
Gull Laboratories, Inc.
Microbiology · 120d
Cleared Dec 28, 1990
MEASLES IGG MICROASSAY
K903961 · LJB
Diamedix Corp.
Microbiology · 122d
Cleared Dec 26, 1990
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 441d