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
3313–3336 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · LSE
Incstar Corp.
Microbiology · 161d
Cleared Sep 11, 1992
ROCHE ENTEROTUBE II
K922588 · JSS
Roche Diagnostic Systems, Inc.
Microbiology · 102d
Cleared Sep 11, 1992
PROSPECT GIARDIA CONTROLS
K922675 · MHI
Alexon, Inc.
Microbiology · 99d
Cleared Sep 11, 1992
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445 · LYR
Hycor Biomedical, Inc.
Microbiology · 65d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGG EIA
K922330 · LJB
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · LJN
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332 · LSE
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGM EIA
K922335 · LJB
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS LYME DISEASE IGM EIA
K922578 · LSR
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Sep 02, 1992
BARTELS TOXOPLASMA IGM EIA
K922579 · LGD
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Sep 02, 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · LGD
Baxter Diagnostics, Inc.
Microbiology · 98d
Cleared Aug 27, 1992
RUBELLA IGM
K921573 · LFX
Clark Laboratories, Inc.
Microbiology · 147d
Cleared Aug 20, 1992
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
K920212 · LJZ
Shared Systems, Inc.
Microbiology · 217d
Cleared Aug 20, 1992
BIOSTARS STREP A OIA -- MODIFICATION
K922765 · GTY
Biosearch Medical Products, Inc.
Microbiology · 79d
Cleared Aug 20, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922780 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 72d
Cleared Aug 19, 1992
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
K922003 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 112d
Cleared Aug 11, 1992
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
K921321 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 148d
Cleared Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · LIN
Incstar Corp.
Microbiology · 127d
Cleared Jul 30, 1992
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · MJH
Whittaker Bioproducts, Inc.
Microbiology · 490d
Cleared Jul 30, 1992
PERMIER HISTOPLASMA
K915700 · MIZ
Meridian Diagnostics, Inc.
Microbiology · 220d
Cleared Jul 30, 1992
AFFIRM VP SAMPLE COLLECTION SET
K920536 · LIO
Microprobe Corp.
Microbiology · 176d
Cleared Jul 30, 1992
TURKEL THORACENTESIS NEEDLE
K921461 · GSS
Symbiosis Corp.
Microbiology · 125d
Cleared Jul 30, 1992
ZITHROMAX
K922792 · JNT
Difco Laboratories, Inc.
Microbiology · 51d
Cleared Jul 28, 1992
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
K921421 · LHL
Pro-Lab, Inc.
Microbiology · 126d