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
3385–3408 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 08, 1992
IMMUNODOT BORRELIA (LYME) TEST
K911627 · LSR
General Biometrics, Inc.
Microbiology · 363d
Cleared Apr 08, 1992
CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K915454 · LIO
Medical Packaging Corp.
Microbiology · 125d
Cleared Apr 08, 1992
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416 · LIB
Behring Diagnostics, Inc.
Microbiology · 68d
Cleared Apr 08, 1992
LORACARBEF 30MCG, SENSI DISC
K920786 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 08, 1992
TEMAFLOXCIN, 5MCG, SENSI DISC
K920787 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 02, 1992
ACCUPACE GROUP A STREPTOCOCCUS ID TEST
K915852 · MDK
Gen-Probe, Inc.
Microbiology · 97d
Cleared Mar 23, 1992
PROSPECT(TM/CRYPTOSPORIDIUM
K912242 · MHJ
Alexon, Inc.
Microbiology · 307d
Cleared Mar 23, 1992
SEROLISA CHLAMYDIA IGG TEST KIT
K915281 · LJC
Savyon Diagnostics , Ltd.
Microbiology · 119d
Cleared Mar 23, 1992
DIRECTIGEN MENINGITIS COMBO TEST KIT
K915330 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 118d
Cleared Mar 23, 1992
CEFPROZIL 30MCG, SENSI DISC
K920473 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 55d
Cleared Mar 23, 1992
BBL STREP GROUPING KIT
K920565 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared Mar 19, 1992
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
K915053 · GTQ
Beckman Instruments, Inc.
Microbiology · 140d
Cleared Mar 18, 1992
VIRATEST-DIA(TM) MEASLES (RUBEOLA)
K910290 · LJB
Virus Reference Laboratory, Inc.
Microbiology · 421d
Cleared Mar 18, 1992
DIRECTIGEN NEISSERIA MENINGITIDIS TEST
K920274 · GTI
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Mar 04, 1992
ENZYGNOST TOXOPLASMOSIS/IGM
K913505 · LGD
Behring Diagnostics, Inc.
Microbiology · 210d
Cleared Mar 04, 1992
ELISA CMV IGM
K914789 · LKQ
Sclavo, Inc.
Microbiology · 133d
Cleared Mar 04, 1992
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902 · LLH
Techlab, Inc.
Microbiology · 124d
Cleared Mar 04, 1992
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · LIQ
Bio-Rad Laboratories, Inc.
Microbiology · 112d
Cleared Mar 04, 1992
GAP IGG H.PYLORI MODIFIED
K915185 · LYR
Biomerica, Inc.
Microbiology · 107d
Cleared Mar 04, 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · LJC
Vitek Systems, Inc.
Microbiology · 83d
Cleared Mar 04, 1992
TOXO IGG ELISA TEST (MODIFIED)
K915891 · LGD
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Mar 04, 1992
RUBELLA IGG ELISA TEST
K915893 · LFX
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Feb 28, 1992
RAMBACH AGAR
K912924 · JSS
Rantran, Inc.
Microbiology · 240d
Cleared Feb 27, 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · LFZ
Behring Diagnostics, Inc.
Microbiology · 192d