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
4897–4920 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 20, 1986
AUSTIN ENTERIC SYSTEM
K860194 · JSE
Austin Biological Laboratories
Microbiology · 29d
Cleared Feb 20, 1986
PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE
K860195 · JWY
Austin Biological Laboratories
Microbiology · 29d
Cleared Feb 06, 1986
RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE
K860301 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 9d
Cleared Feb 05, 1986
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
K853484 · GNP
Biotech Research Laboratories, Inc.
Microbiology · 169d
Cleared Feb 05, 1986
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
K854577 · JWY
Austin Biological Laboratories
Microbiology · 105d
Cleared Feb 05, 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · GQI
Clinical Sciences, Inc.
Microbiology · 76d
Cleared Feb 05, 1986
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
K855205 · JSI
Hana Biologics, Inc.
Microbiology · 37d
Cleared Feb 05, 1986
PYR DISCS
K860302 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Feb 04, 1986
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
K853540 · GQX
Idt, A Division of Whittaker M.A....
Microbiology · 165d
Cleared Feb 04, 1986
ORTHO HSV ANTIGEN ELISA TEST
K854488 · GQN
Ortho Diagnostic Systems, Inc.
Microbiology · 88d
Cleared Feb 04, 1986
CYTOMEGELISA M TEST KIT
K854839 · LKQ
Whittaker Bioproducts, Inc.
Microbiology · 62d
Cleared Feb 04, 1986
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
K854851 · GTJ
Wellcome Diagnostics
Microbiology · 61d
Cleared Feb 04, 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
K854852 · GTJ
Wellcome Diagnostics
Microbiology · 61d
Cleared Jan 28, 1986
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
K854615 · LKI
Serono Diagnostics, Inc.
Microbiology · 71d
Cleared Jan 24, 1986
CEFACLOR 30 MCG SENSITIVITY DISCS
K855206 · JTN
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Jan 24, 1986
STREP D FLUOR
K860041 · GTP
Bio Spec, Inc.
Microbiology · 18d
Cleared Jan 21, 1986
HSV2 - IGG ELISA-KIT
K852781 · GQO
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
HSVI - IGG ELISA-KIT
K852782 · GQO
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
PASCO RESISTANT 5 PANEL
K853862 · JWY
Pasco Laboratories, Inc.
Microbiology · 126d
Cleared Jan 21, 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · LIQ
Orion Diagnostica, Inc.
Microbiology · 104d
Cleared Jan 21, 1986
BIO SPEC GRAMAFLUOR TEST KIT
K860091 · JTO
Bio Spec, Inc.
Microbiology · 11d
Cleared Jan 14, 1986
INDI KWIK (TM) CO/TWO KIT
K855198 · JTR
Micro-Bio-Logics
Microbiology · 18d
Cleared Jan 13, 1986
CEFACLOR SENSI-DISC
K855135 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 07, 1986
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K855110 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 15d