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
3865–3888 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 20, 1989
EBNA-CHECK(TM) TEST KIT
K891542 · LLM
Diagnostic Technology, Inc.
Microbiology · 95d
Cleared Jun 20, 1989
HSV-2 ELISA TEST SYSTEM
K891782 · GQL
Zeus Scientific, Inc.
Microbiology · 88d
Cleared Jun 15, 1989
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
K891990 · LJB
Clinical Sciences, Inc.
Microbiology · 79d
Cleared Jun 13, 1989
SUPER DUO
K892802 · JWZ
Mercia Diagnostics , Ltd.
Microbiology · 57d
Cleared Jun 13, 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · JSO
Remel Co.
Microbiology · 53d
Cleared Jun 09, 1989
QUIK-DOT TOXOPLASMOSIS
K890048 · LLA
Ampcor, Inc.
Microbiology · 154d
Cleared Jun 09, 1989
SENSITITRE AUTO ID PLATE AP80
K890057 · LQM
Radiometer America, Inc.
Microbiology · 154d
Cleared Jun 09, 1989
LISTERIA SELECTIVE ENRICHMENT MEDIUM
K891593 · JSI
Oxoid U.S.A., Inc.
Microbiology · 81d
Cleared Jun 08, 1989
RUBELLA-CUBE(TM)
K892051 · LFX
Difco Laboratories, Inc.
Microbiology · 71d
Cleared Jun 06, 1989
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
K891382 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Jun 02, 1989
GERM TUBE SOLUTION
K884720 · JXC
Remel Co.
Microbiology · 204d
Cleared Jun 02, 1989
RAPIDEC COLI
K890626 · JSS
Dms Products, Inc.
Microbiology · 115d
Cleared Jun 02, 1989
CMV ELISA TEST SYSTEM
K891081 · LFZ
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Jun 02, 1989
SCEPTOR DATA MANAGEMENT CENTER SOFTWARE
K891577 · LON
Bd Becton Dickinson Vacutainer...
Microbiology · 74d
Cleared Jun 02, 1989
MULTI-PROBE HEAD PLUS
K892369 · JTC
Hamilton Co.
Microbiology · 57d
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · LJC
Abbott Laboratories
Microbiology · 57d
Cleared May 24, 1989
MERIFLUOR(TM) -TRICHOMONAS
K892263 · JWZ
Meridian Diagnostics, Inc.
Microbiology · 50d
Cleared May 15, 1989
VZV MICROASSAY
K890642 · LFY
Diamedix Corp.
Microbiology · 96d
Cleared May 11, 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
K883600 · LLM
Clinical Sciences, Inc.
Microbiology · 261d
Cleared May 11, 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
K883601 · LLM
Clinical Sciences, Inc.
Microbiology · 261d
Cleared May 10, 1989
STAT TEST KIT FOR EB-VCA IGG ANTIBODY
K891086 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared May 04, 1989
SELECTIVE RAPID UREA
K883641 · LYR
Remel Co.
Microbiology · 252d
Cleared May 01, 1989
MICROTRAK EIA AUTOWASHER
K891269 · JYC
Syva Co.
Microbiology · 53d
Cleared May 01, 1989
GENETIC SYSTEMS PIPETTOR/DILUTOR
K891765 · JTC
Genetic Systems Corp.
Microbiology · 38d