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
2065–2088 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · JTN
Hardy Diagnostics
Microbiology · 43d
Cleared Jan 09, 2001
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K003619 · LTT
Dade Microscan, Inc.
Microbiology · 48d
Cleared Dec 13, 2000
HARDY DISK, CEFPODOXINE, 10MCG
K003532 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Nov 29, 2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · LIP
Trinity Biotech, Plc
Microbiology · 197d
Cleared Nov 28, 2000
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · LGC
Diamedix Corp.
Microbiology · 126d
Cleared Nov 22, 2000
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM...
K002024 · GRY
Panbio, Inc.
Microbiology · 142d
Cleared Nov 22, 2000
C. DIFFICILE TOX A/B II
K003306 · LLH
Techlab, Inc.
Microbiology · 33d
Cleared Nov 13, 2000
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
K001177 · LYR
Enteric Products, Inc.
Microbiology · 216d
Cleared Nov 13, 2000
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023 · LYR
Medmira Laboratories, Inc.
Microbiology · 133d
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139 · LTX
Ab Biodisk
Microbiology · 114d
Cleared Nov 07, 2000
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
K003204 · GNW
Intracel Corp.
Microbiology · 25d
Cleared Nov 02, 2000
HARDYDISK CLINDAMYCIN, 2MCG
K002662 · JTN
Hardy Diagnostics
Microbiology · 69d
Cleared Nov 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 29d
Cleared Oct 26, 2000
HARDY DISK CEFTIZOXIME, 30MCG
K002367 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
HARDYDISK GENTAMICIN, 120MCG
K002369 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
HARDYDISK LOMEFLOXACIN, 10MCG
K002660 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK CEFOTETAN, 30MCG
K002661 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK LEVOFLOXACIN, 5MCG
K002664 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 25, 2000
HARDYDISK STREPTOMYCIN, 300MCG
K002368 · JTN
Hardy Diagnostics
Microbiology · 83d
Cleared Oct 25, 2000
HARDYDISK CEFUROXIME, 30MCG
K002656 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Oct 20, 2000
BACT/ALERT CSR
K003104 · LJF
Organon Teknika Corp.
Microbiology · 52d
Cleared Oct 19, 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · LIP
Phoenix Biotech Corp.
Microbiology · 154d
Cleared Oct 19, 2000
HARDYDISK NETILMICIN, 30MCG
K002663 · JTN
Hardy Diagnostics
Microbiology · 55d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · LYR
bioMerieux, Inc.
Microbiology · 147d