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
2401–2424 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 29, 1998
ETEST CHLORAMPHENICAL
K980342 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 29, 1998
ETEST VANCOMYCIN
K980348 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 28, 1998
ETEST OFLOXACIN
K980338 · JWY
Ab Biodisk
Microbiology · 120d
Cleared May 28, 1998
ETEST TETRACYCLINE
K981134 · JWY
Ab Biodisk
Microbiology · 59d
Cleared May 27, 1998
ETEST CEFTRIAXONE
K980345 · JWY
Ab Biodisk
Microbiology · 118d
Cleared May 27, 1998
ETEST TETRACYCLINE
K980347 · JWY
Ab Biodisk
Microbiology · 119d
Cleared May 18, 1998
CRYPTOSPORIDIUM TEST
K980354 · MHJ
Techlab, Inc.
Microbiology · 109d
Cleared May 18, 1998
ETEST GREPAFLOXACIN
K980773 · JWY
Ab Biodisk
Microbiology · 77d
Cleared May 18, 1998
PASCO MIC AND MIC/ID PANELS
K980955 · JTN
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared May 13, 1998
ETEST TROVAFLOXACIN
K980603 · JWY
Ab Biodisk
Microbiology · 85d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076 · LYR
Meridian Diagnostics, Inc.
Microbiology · 124d
Cleared May 01, 1998
CMVGEN
K974456 · LJO
Instrumentation Laboratory CO
Microbiology · 157d
Cleared May 01, 1998
BACTEC MGIT 960 SYSTEM
K974883 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 122d
Cleared May 01, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · LLM
Clark Laboratories, Inc.
Microbiology · 73d
Cleared May 01, 1998
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 67d
Cleared Apr 23, 1998
SERAQUEST MUMPS IGG
K980059 · LJY
Quest Intl., Inc.
Microbiology · 106d
Cleared Apr 23, 1998
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507 · GMZ
Alexon - Trend, Inc.
Microbiology · 72d
Cleared Apr 09, 1998
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
K970761 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
HUMAN LYME IGM WESTERN BLOT KIT
K970768 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · GNW
Light Diagnostics
Microbiology · 142d
Cleared Apr 02, 1998
PARA-PAK SPINCON
K980077 · LKS
Meridian Diagnostics, Inc.
Microbiology · 84d
Cleared Mar 26, 1998
EA-D IGG ELISA TEST SYSTEM
K973123 · LSE
Clark Laboratories, Inc.
Microbiology · 218d
Cleared Mar 20, 1998
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881 · MCB
Biosite Incorporated
Microbiology · 80d
Cleared Mar 17, 1998
SHIELD HELICO-G2 ELISA KIT
K972981 · LYR
Shield Diagnostics, Ltd.
Microbiology · 218d