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
4081–4104 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 25, 1988
ATS NAC-PAC SET
K881949 · JSK
Alpha-Tec Systems, Inc.
Microbiology · 15d
Cleared May 23, 1988
EBNA ANTIBODY
K875170 · LLM
Hillcrest Biologicals
Microbiology · 158d
Cleared May 23, 1988
THE DDI SERODOT HERPES IGG TEST KIT
K875366 · GQO
Disease Detection International, Inc.
Microbiology · 144d
Cleared May 23, 1988
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · GMQ
Stanbio Laboratory
Microbiology · 131d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469 · LJC
Abbott Laboratories
Microbiology · 110d
Cleared May 18, 1988
MODIFIED IDS RAPID NH SYSTEM
K881501 · JSX
Innovative Diagnostic Systems, Inc.
Microbiology · 37d
Cleared May 13, 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541 · LJN
Ortho Diagnostic Systems, Inc.
Microbiology · 319d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881 · LKQ
Abbott Laboratories
Microbiology · 296d
Cleared May 13, 1988
SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
K873565 · LIO
Molecular Biosystems, Inc.
Microbiology · 254d
Cleared May 13, 1988
TRICHOMATE(R) SUPER
K875138 · JWZ
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared May 13, 1988
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361 · LFZ
Disease Detection International, Inc.
Microbiology · 134d
Cleared May 13, 1988
SENSITITRE STABILITY PLATES
K880641 · JWY
Sensititre , Ltd.
Microbiology · 92d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
K880996 · GQN
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
K881180 · GQN
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127 · GQG
Abbott Laboratories
Microbiology · 206d
Cleared May 06, 1988
CATHRA GRAM POSITIVE SCREEN
K874606 · LQL
Mct Medical, Inc.
Microbiology · 179d
Cleared May 06, 1988
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · GQI
Gull Laboratories, Inc.
Microbiology · 142d
Cleared May 06, 1988
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · LIQ
Abbott Laboratories
Microbiology · 66d
Cleared May 04, 1988
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER
K880574 · JTT
Merck, Sharp & Dohme
Microbiology · 84d
Cleared Apr 28, 1988
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
K881439 · JXA
Los Alamos Diagnostics
Microbiology · 23d
Cleared Apr 27, 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · LJP
Ortho Diagnostic Systems, Inc.
Microbiology · 16d
Cleared Apr 27, 1988
BREWER GEL FOR CAMPYLOBACTER
K881502 · KZJ
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 16d
Cleared Apr 26, 1988
LYME DISEASE ELISA
K880476 · LSR
Hillcrest Biologicals
Microbiology · 82d
Cleared Apr 25, 1988
CULTURE COLLECTION DEVICE
K881105 · JSM
Medical Packaging Corp.
Microbiology · 41d