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
3697–3720 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 26, 1990
RESUBMITTED MODIFIED RUBALEX
K901637 · LQN
Orion Corp.
Microbiology · 17d
Cleared Apr 16, 1990
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
K896492 · LQF
Gen-Probe, Inc.
Microbiology · 154d
Cleared Apr 16, 1990
TOXO IGG ELISA TEST
K900354 · LGD
Gull Laboratories, Inc.
Microbiology · 81d
Cleared Apr 16, 1990
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · LJP
Diagnostic Products Corp.
Microbiology · 51d
Cleared Apr 16, 1990
INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
K900974 · JRY
Stellar Bio Systems, Inc.
Microbiology · 45d
Cleared Apr 16, 1990
DMAC INDOLE REAGENT
K901390 · JTO
Analytical Products, Inc.
Microbiology · 21d
Cleared Apr 11, 1990
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
K896493 · LQF
Gen-Probe, Inc.
Microbiology · 149d
Cleared Apr 10, 1990
VISUWELL(R) REAGIN TEST (MODIFICATION)
K900338 · GMQ
Adi Diagnostics, Inc.
Microbiology · 77d
Cleared Apr 05, 1990
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
K901054 · LSR
Bion Ent., Ltd.
Microbiology · 30d
Cleared Apr 03, 1990
SNAP MYCOBACTERIA AVIUM COMPLEX
K900202 · LQF
Syngene, Inc.
Microbiology · 77d
Cleared Apr 03, 1990
SNAP M. TUBERCULOSIS COMPLEX
K900292 · LQF
Syngene, Inc.
Microbiology · 71d
Cleared Mar 23, 1990
PLATELIA TOXO IGG KIT
K894947 · LGO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 232d
Cleared Mar 15, 1990
PLATELIA TOXO IGM KIT
K894948 · LGD
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 224d
Cleared Mar 15, 1990
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Mar 13, 1990
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
K895468 · LJC
Orgenics, Ltd.
Microbiology · 183d
Cleared Mar 13, 1990
RAPID NF SYSTEM
K900517 · JSW
Innovative Diagnostic Systems, Inc.
Microbiology · 39d
Cleared Mar 12, 1990
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915 · MCB
Meridian Diagnostics, Inc.
Microbiology · 153d
Cleared Mar 08, 1990
ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE
K897079 · MCC
Gen-Probe, Inc.
Microbiology · 76d
Cleared Mar 08, 1990
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
K900402 · LJC
Eastman Kodak Company
Microbiology · 38d
Cleared Mar 08, 1990
MODIFIED CAPTIA(R) SYPHILIS-M
K900654 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 27d
Cleared Mar 07, 1990
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 127d
Cleared Mar 06, 1990
CAPTIA(R) CMV-G
K896194 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 132d
Cleared Mar 06, 1990
CAPTIA(R) CMV-M
K896295 · LFZ
Mercia Diagnostics , Ltd.
Microbiology · 126d
Cleared Mar 06, 1990
MODIFIED CAPTIA(R) TOXO-M
K900655 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 25d