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
3985–4008 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 27, 1988
SCEPTORPETTE SYSTEM
K883907 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Oct 25, 1988
STREPSLIDE
K882811 · GTY
Ncs Diagnostics, Inc.
Microbiology · 110d
Cleared Oct 25, 1988
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K883083 · GSA
Medical Diagnostic Technologies, Inc.
Microbiology · 96d
Cleared Oct 25, 1988
FDL ELISA FOR CHLAMYDIA
K883266 · LJC
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 83d
Cleared Oct 25, 1988
CDT CYTOTOXI TEST
K883560 · LLH
Advanced Clinical Diagnostics
Microbiology · 67d
Cleared Oct 25, 1988
RUBELLA IGM MICROASSAY
K883778 · LFX
Diamedix Corp.
Microbiology · 49d
Cleared Oct 25, 1988
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
K884208 · KZI
Oxoid U.S.A., Inc.
Microbiology · 19d
Cleared Oct 12, 1988
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Oct 12, 1988
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
K883800 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Oct 12, 1988
X-ACT UREA/TDA
K883995 · JSE
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
X-ACT LDC/IND
K883996 · JSE
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
QUIDEL GROUP A STREP TEST
K883999 · GTZ
Quidel Corp.
Microbiology · 23d
Cleared Oct 06, 1988
B. FRAGTEX
K881380 · JSP
American Biomedical Products, Inc.
Microbiology · 188d
Cleared Oct 06, 1988
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
K882199 · LYR
Auspharm Intl. , Ltd.
Microbiology · 134d
Cleared Oct 06, 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · LFX
Amersham Corp.
Microbiology · 113d
Cleared Oct 06, 1988
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · LJP
Whittaker Bioproducts, Inc.
Microbiology · 58d
Cleared Oct 06, 1988
HISTO-CHECK LEGIONELLA CONTROL SLIDES
K883567 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK ACID FAST SLIDES
K883568 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK GRAM NEGATIVE SLIDES
K883569 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK FUNGAL CONTROL SLIDES
K883570 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK PARASITIC CONTROL SLIDES
K883571 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · LGD
Ortho Diagnostic Systems, Inc.
Microbiology · 17d
Cleared Sep 30, 1988
TOXOPLASMA GONDII IGG ELISA KIT
K875258 · LGD
De Ferris Laboratories, Inc.
Microbiology · 283d
Cleared Sep 30, 1988
URISCREEN
K882211 · JXA
Diatech Diagnostica , Ltd.
Microbiology · 127d