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
5401–5424 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 14, 1984
ROTALEX LATEX AGGLUTINATION TEST
K841319 · LIQ
Orion Diagnostica, Inc.
Microbiology · 165d
Cleared Sep 14, 1984
MICROBIOLOGICAL TRAY READER-MANUAL
K842947 · JJQ
American Micro Scan
Microbiology · 50d
Cleared Sep 14, 1984
STREP SELECTIVE II
K843193 · JSI
Remel Co.
Microbiology · 31d
Cleared Sep 14, 1984
V AGAR SELECTIVE DEEPS
K843194 · JSI
Remel Co.
Microbiology · 31d
Cleared Sep 14, 1984
T.I.M.E. DISPENSER
K843272 · JTC
Dynatech Laboratories, Inc.
Microbiology · 25d
Cleared Sep 13, 1984
ID ZINE LD ISOENZYME CONTROL ABNORM
K843265 · JJT
Beckman Instruments, Inc.
Microbiology · 24d
Cleared Sep 12, 1984
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · JTA
American Micro Scan
Microbiology · 51d
Cleared Sep 12, 1984
APPLELISA CHLAMYDIA TRACHOMATIS ANTI
K843120 · LJC
Apple Diagnostic Products
Microbiology · 35d
Cleared Sep 11, 1984
GIARDIA GUARD
K842052 · LIB
Gelman Sciences, Inc.
Microbiology · 112d
Cleared Sep 11, 1984
GRAM STAIN
K843050 · JTS
Reagent Laboratory, Inc.
Microbiology · 39d
Cleared Sep 11, 1984
INDOLE SPOT TEST KIT 270-25
K843316 · JTO
Applied Polytechnology, Inc.
Microbiology · 18d
Cleared Sep 07, 1984
CMV LATEX AGGLUTINATION TEST KIT
K841520 · LJO
Bd Becton Dickinson Vacutainer...
Microbiology · 148d
Cleared Sep 07, 1984
AMIZYME-TOXOPLASMA GONDII KIT
K842528 · LGD
Amico Lab, Inc.
Microbiology · 71d
Cleared Sep 07, 1984
AUGMENTIN 30 MCG SENSITIVITY DISKS
K843172 · JTN
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Sep 07, 1984
DIFFERENTIATION DISKS BILE ESCULIN
K843364 · JSF
Difco Laboratories, Inc.
Microbiology · 10d
Cleared Sep 06, 1984
CELL-MATICS VIRAL TRANSPORT PACK
K843173 · JTW
Difco Laboratories, Inc.
Microbiology · 24d
Cleared Sep 05, 1984
AMIZYME-SCHISTOSOMA SPP. TEST KIT
K842527 · GNH
Amico Lab, Inc.
Microbiology · 69d
Cleared Aug 28, 1984
RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA
K843085 · KIT
Sigma Chemical Co.
Microbiology · 22d
Cleared Aug 28, 1984
DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX
K843086 · KIT
Sigma Chemical Co.
Microbiology · 22d
Cleared Aug 23, 1984
AUGMENTIN 30 MCG SENSI DISC
K842253 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 77d
Cleared Aug 20, 1984
MINIMUM ESSENTIAL MED W/L-GLUTAMINE
K842776 · KIT
Sigma Chemical Co.
Microbiology · 35d
Cleared Aug 20, 1984
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
K843065 · KZI
Otisville Biotech, Inc.
Microbiology · 14d
Cleared Aug 20, 1984
BIOTIS CIN AGAR PLATES
K843066 · JSI
Otisville Biotech, Inc.
Microbiology · 14d
Cleared Aug 17, 1984
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB
K842775 · KIT
Sigma Chemical Co.
Microbiology · 32d