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
3433–3456 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 05, 1991
LYME-CHECK(TM) TEST KIT
K896378 · LSR
Diagnostic Technology, Inc.
Microbiology · 729d
Cleared Oct 31, 1991
OIA STREP A
K912889 · GTZ
Biosearch Medical Products, Inc.
Microbiology · 122d
Cleared Oct 28, 1991
SCEPTOR IDENTIFICATION SYSTEM
K912897 · LQM
Bd Becton Dickinson Vacutainer...
Microbiology · 119d
Cleared Oct 28, 1991
OPUS(R) ANTI CMV-M
K913080 · LKQ
Pb Diagnostics, Inc.
Microbiology · 109d
Cleared Oct 21, 1991
LYME STAT M TEST KIT
K904652 · LSR
Whittaker Bioproducts, Inc.
Microbiology · 371d
Cleared Oct 21, 1991
PYLORISET
K904655 · LYR
Orion Diagnostica, Inc.
Microbiology · 374d
Cleared Oct 18, 1991
BIOKIT RPR
K910541 · GMQ
Biokit USA, Inc.
Microbiology · 256d
Cleared Oct 16, 1991
FIAX LYME M TEST KIT
K904893 · LSR
Whittaker Bioproducts, Inc.
Microbiology · 351d
Cleared Oct 11, 1991
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · LLH
Vitek Systems, Inc.
Microbiology · 325d
Cleared Oct 11, 1991
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · LYR
Hycor Biomedical, Inc.
Microbiology · 142d
Cleared Oct 11, 1991
VISI-NEISSERIA
K913456 · JSX
Kev Connecticut Diagnostics, Inc.
Microbiology · 67d
Cleared Oct 09, 1991
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 47d
Cleared Oct 07, 1991
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST
K911362 · LJN
Amico Laboratories, Inc.
Microbiology · 193d
Cleared Oct 04, 1991
URI-THREE(TM), MODIFICATION
K911846 · JXA
Culture Kits, Inc.
Microbiology · 169d
Cleared Oct 04, 1991
PYLORITRAK
K912215 · LYR
Bainbridge Laboratories, Inc.
Microbiology · 137d
Cleared Sep 27, 1991
PROSPEC T/GIARDIA RAPID ASSAY
K911337 · MHI
Alexon, Inc.
Microbiology · 185d
Cleared Sep 27, 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · LKT
Baxter Diagnostics, Inc.
Microbiology · 93d
Cleared Sep 25, 1991
EBNA STAT TEST KIT
K911473 · LLM
Whittaker Bioproducts, Inc.
Microbiology · 174d
Cleared Sep 25, 1991
THE E TEST, MODIFICATION
K913459 · JWY
Ab Biodisk
Microbiology · 51d
Cleared Sep 23, 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · LKT
Vitek Systems, Inc.
Microbiology · 117d
Cleared Sep 23, 1991
BACTIDROP(TM) FERRIC CHLORIDE (10%)
K913002 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) VOGES-PROSKAUER A
K913003 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) DOBELL & O'CONNOR IODINE
K913006 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) VOGES-PROSKAUER B
K913007 · JTO
Remel Co.
Microbiology · 77d