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
4753–4776 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 03, 1986
BIOTIS ACETAMIDE AGAR
K862389 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS BORDET GENGOU AGAR
K862390 · KZI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DESOXYCHOLATE AGAR
K862391 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS MOTILITY TEST MEDIUM
K862392 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS LITMUS MILK
K862393 · JSE
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS MITIS SALIVARIUS
K862394 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, BASE
K862395 · JSH
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, ARGININE
K862396 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, LYSINE
K862397 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
K862398 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS SXT AGAR
K862399 · JSJ
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS KV LAKED BLOOD AGAR
K862400 · JSJ
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 02, 1986
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM
K860782 · LQF
Gen-Probe, Inc.
Microbiology · 121d
Cleared Jul 02, 1986
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
K862425 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 6d
Cleared Jul 01, 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · LIQ
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 95d
Cleared Jun 30, 1986
RAPID BACTERIURIA SCREEN (RBS)
K862195 · JXA
New Horizons Diagnostics Co.
Microbiology · 21d
Cleared Jun 30, 1986
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
K862216 · LGD
Labsystems, Inc.
Microbiology · 20d
Cleared Jun 25, 1986
HYGEIA RAPID STREP A TEST
K862133 · GTY
Hygeia Sciences
Microbiology · 21d
Cleared Jun 17, 1986
RUBELLA IGG EIA TEST KIT
K853696 · LFX
Labsystems, Inc.
Microbiology · 285d
Cleared Jun 17, 1986
GRAM NEGATIVE COMBO PANEL TYPE 3
K861584 · JWY
American Micro Scan
Microbiology · 49d
Cleared Jun 16, 1986
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 77d
Cleared Jun 16, 1986
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K862123 · KZJ
Marion Laboratories, Inc.
Microbiology · 13d
Cleared Jun 13, 1986
COR DOT CMV
K853989 · GQI
Cordis Corp.
Microbiology · 259d
Cleared Jun 13, 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 74d