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
4465–4488 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 30, 1987
TOXOPLASMA GONDII IGG ELISA
K871905 · LGD
Electro-Nucleonics Laboratories, Inc.
Microbiology · 76d
Cleared Jul 27, 1987
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared Jul 23, 1987
FLUORTRAN - C(TM)
K872751 · LIO
Para Scientific Co.
Microbiology · 10d
Cleared Jul 20, 1987
ENZYGNOST ANTI-CMV IGG TEST
K863488 · GQI
Behring Diagnostics, Inc.
Microbiology · 314d
Cleared Jul 16, 1987
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
K870176 · LKT
Genetic Systems Corp.
Microbiology · 182d
Cleared Jul 09, 1987
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K872465 · KIT
J R Scientific
Microbiology · 16d
Cleared Jul 09, 1987
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K872507 · JSM
Precision Dynamics Corp.
Microbiology · 15d
Cleared Jul 01, 1987
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
K872252 · LGD
Labsystems, Inc.
Microbiology · 20d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
K871228 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
K871229 · GOD
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
K871230 · LKT
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
K871231 · GNX
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3
K871232 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
K871233 · GNX
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
K871234 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 25, 1987
EBNA ACIF ASSAY KIT
K871298 · LLM
Granbio, Inc.
Microbiology · 86d
Cleared Jun 25, 1987
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · GNP
Diagnostic Technology, Inc.
Microbiology · 79d
Cleared Jun 24, 1987
MACCONKEY W/SORBITOL
K872188 · JSI
Remel Co.
Microbiology · 16d
Cleared Jun 23, 1987
TRANSTUBE MW176 OT MD176
K872213 · JSM
Medical Wire & Equipment Co.
Microbiology · 14d
Cleared Jun 22, 1987
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
K872193 · KZI
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Jun 17, 1987
LYFO KWIK(TM) RUS KIT
K870731 · JXA
Micro-Bio-Logics
Microbiology · 112d
Cleared Jun 17, 1987
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
K871620 · GTZ
Allelix, Inc.
Microbiology · 51d
Cleared Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831 · GTZ
Diagnostic Products Corp.
Microbiology · 37d
Cleared Jun 15, 1987
SENSIR SYSTEM
K870719 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 115d