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
2161–2184 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 09, 2000
HSV-1 ELISA IGG, MODEL EL0910G
K993754 · MXJ
Mrl Diagnostics
Microbiology · 96d
Cleared Feb 01, 2000
HSV-2 ELISA IGG, MODEL EL0920G
K993724 · MYF
Mrl Diagnostics
Microbiology · 90d
Cleared Feb 01, 2000
HARDYDISK CEFACLOR 30MCG
K994046 · JTN
Hardy Diagnostics
Microbiology · 64d
Cleared Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004 · LSR
Inova Diagnostics, Inc.
Microbiology · 64d
Cleared Jan 18, 2000
OSOM ULTRA STREP A TEST, MODEL 147
K992658 · GTY
Wyntek Diagnostics, Inc.
Microbiology · 162d
Cleared Jan 18, 2000
HARDYDISK IMIPENEM, 10MCG
K994132 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Jan 14, 2000
MICROSTREP PLUS PANEL, VANCOMYCIN
K983953 · JWY
Dade Microscan, Inc.
Microbiology · 435d
Cleared Jan 14, 2000
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
K993679 · JWY
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jan 14, 2000
HARDYDISK AZTREONAM, 30MCG
K994063 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Jan 14, 2000
HARDY DISK AMPICILLIN/SULBACTAM
K994067 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Jan 10, 2000
HARDYDISK DOXYCYCLINE, 30MCG
K994051 · JTN
Hardy Diagnostics
Microbiology · 41d
Cleared Dec 27, 1999
HARDYDISK AMIKACIN 30MCG
K993993 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Dec 22, 1999
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587 · LSE
Stellar Bio Systems, Inc.
Microbiology · 142d
Cleared Dec 21, 1999
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
K991074 · MJH
Intracel Corp.
Microbiology · 265d
Cleared Dec 21, 1999
UNI-GOLD H. PYLORI
K991697 · LYR
Trinity Biotech, Plc
Microbiology · 217d
Cleared Dec 21, 1999
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL...
K993812 · JSM
Hardy Diagnostics
Microbiology · 41d
Cleared Dec 21, 1999
HARDYDISK AZITHROMYCIN 15MCG
K993994 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Dec 21, 1999
E. HISTOLYTICA II
K994101 · KHW
Techlab, Inc.
Microbiology · 15d
Cleared Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048 · PSZ
Roche Diagnostics Corp.
Microbiology · 101d
Cleared Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · LIP
DiaSorin, Inc.
Microbiology · 139d
Cleared Dec 16, 1999
INTRAY GC
K993033 · JTY
Biomed Diagnostics, Inc.
Microbiology · 98d
Cleared Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · LFZ
Diagnostic Products Corp.
Microbiology · 24d
Cleared Dec 15, 1999
BACT/ALERT SA
K993423 · MDB
Organon Teknika Corp.
Microbiology · 64d
Cleared Dec 14, 1999
BACT/ALERT SN
K993421 · MDB
Organon Teknika Corp.
Microbiology · 63d