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
3409–3432 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 21, 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · LYR
Quidel Corp.
Microbiology · 56d
Cleared Feb 19, 1992
IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
K914953 · LKI
Stellar Bio Systems, Inc.
Microbiology · 106d
Cleared Feb 18, 1992
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K912778 · JWY
Sensititre Microbiology A Div. of...
Microbiology · 239d
Cleared Feb 14, 1992
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · LIQ
Dako Corp.
Microbiology · 241d
Cleared Feb 14, 1992
EBV-VCA IGM ELISA
K915348 · LJN
Pharmacia Diagnostics, Inc.
Microbiology · 80d
Cleared Feb 14, 1992
CMV IGG ELISA TEST
K915892 · LFZ
Gull Laboratories, Inc.
Microbiology · 52d
Cleared Feb 06, 1992
CLARITHROMYCIN 15MCG SENSI DISC
K920131 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Jan 30, 1992
PROSPECT(TM) GIARDIA RAPID ASSAY
K915093 · MHI
Alexon, Inc.
Microbiology · 79d
Cleared Jan 30, 1992
STREP A OIA
K915758 · GTZ
Biosearch Medical Products, Inc.
Microbiology · 38d
Cleared Jan 27, 1992
SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS
K914022 · LFY
Pharmacia Diagnostics, Inc.
Microbiology · 140d
Cleared Jan 23, 1992
ELISA TOXO IGM
K914852 · LGD
Sclavo, Inc.
Microbiology · 87d
Cleared Dec 30, 1991
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599 · LSR
General Biometrics, Inc.
Microbiology · 265d
Cleared Dec 27, 1991
ELISA RUBELLA IGM
K914420 · LFX
Sclavo, Inc.
Microbiology · 85d
Cleared Dec 20, 1991
IMMUNOWELL BORRELIA (LYME)TEST
K911590 · LSR
General Biometrics, Inc.
Microbiology · 255d
Cleared Dec 18, 1991
TOXOPLASMA IGM ELISA TEST SYSTEM
K913787 · LGD
Zeus Scientific, Inc.
Microbiology · 117d
Cleared Dec 18, 1991
VIRAPURE, CHLAMYPURE AND MYCOPURE
K914894 · JSM
Microtest
Microbiology · 48d
Cleared Dec 17, 1991
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · GNW
Gull Laboratories, Inc.
Microbiology · 144d
Cleared Dec 13, 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214 · GNW
Gull Laboratories, Inc.
Microbiology · 147d
Cleared Dec 09, 1991
RSV-MAB TEST
K912842 · LKT
Gull Laboratories, Inc.
Microbiology · 166d
Cleared Dec 04, 1991
CMV-EA MAB TEST
K912592 · LIN
Gull Laboratories, Inc.
Microbiology · 177d
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · LGD
Abbott Laboratories
Microbiology · 140d
Cleared Nov 19, 1991
WALKAWAY TM 40
K911400 · LRG
Baxter Healthcare Corp
Microbiology · 235d
Cleared Nov 19, 1991
MARLOW SUCTION/IRRIGATION PROBES
K914872 · GSJ
Marlo Surgical Technology
Microbiology · 21d
Cleared Nov 07, 1991
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
K905608 · GQL
Stellar Bio Systems, Inc.
Microbiology · 328d