Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
2041–2064 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · LSL
Gen-Probe, Inc.
Microbiology · 201d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Hardy Diagnostics
Microbiology · 11d
Cleared May 10, 2001
IMMUNETICS C6 LYME ELISA KIT
K003754 · LSR
Immunetics, Inc.
Microbiology · 156d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · GTY
Quidel Corp.
Microbiology · 27d
Cleared May 07, 2001
ACON STREP A RAPID TEST STRIP
K010582 · GTY
Acon Laboratories Co.
Microbiology · 69d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Hardy Diagnostics
Microbiology · 16d
Cleared Apr 24, 2001
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010537 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · LTT
Pasco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 23, 2001
PASCO MIC AND MIC/ID PANELS
K010508 · LTT
Pasco Laboratories, Inc.
Microbiology · 61d
Cleared Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · LGC
Diagnostic Products Corp.
Microbiology · 30d
Cleared Apr 13, 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · LFX
Bayer Corp.
Microbiology · 162d
Cleared Apr 09, 2001
ETEST MEROPENEM
K010363 · JWY
Ab Biodisk
Microbiology · 61d
Cleared Mar 30, 2001
ELISA TEST, SEROLOGY
K003794 · LYR
Micro Detect, Inc.
Microbiology · 112d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · GTZ
Binax, Inc.
Microbiology · 21d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Jan 19, 2001
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE...
K000884 · NDZ
Becton Dickinson Biosciences
Microbiology · 305d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · JTN
Hardy Diagnostics
Microbiology · 57d