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
2233–2256 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 03, 1999
BACT/ALERT PF
K992401 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS
K992059 · JWY
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · JTN
Pasco Laboratories, Inc.
Microbiology · 70d
Cleared Aug 27, 1999
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12...
K991726 · GTZ
Binax, Inc.
Microbiology · 99d
Cleared Aug 26, 1999
PASCO MIC AND MIC/ID PANELS
K991925 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 19, 1999
POCKIT HSV 2 RAPID TEST
K983886 · LGC
Diagnology , Ltd.
Microbiology · 290d
Cleared Aug 19, 1999
SAS ADENO TEST
K990630 · GOD
Sa Scientific, Inc.
Microbiology · 174d
Cleared Aug 19, 1999
STREP B OIA
K991828 · GTY
Biostar, Inc.
Microbiology · 83d
Cleared Aug 12, 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT...
K991820 · LYR
Zeus Scientific, Inc.
Microbiology · 77d
Cleared Aug 11, 1999
GONOSTAT GONOCOCCAL DETECTION KIT
K991268 · LSL
Sierra Diagnostics
Microbiology · 120d
Cleared Aug 10, 1999
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K992252 · LYF
Chemicon Intl., Inc.
Microbiology · 35d
Cleared Aug 09, 1999
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · GMZ
Meridian Diagnostics, Inc.
Microbiology · 194d
Cleared Aug 09, 1999
SAS ROTA TEST
K990842 · LIQ
Sa Scientific, Inc.
Microbiology · 147d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 674d
Cleared Aug 04, 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · LYR
Quidel Corp.
Microbiology · 75d
Cleared Jul 20, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · LFX
Zeus Scientific, Inc.
Microbiology · 239d
Cleared Jul 13, 1999
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
K972772 · MJA
Trek Diagnostic Systems, Inc.
Microbiology · 719d
Cleared Jul 12, 1999
CMV BRITE TURBO KIT
K991650 · LIN
Biotest Diagnostics Corp.
Microbiology · 60d
Cleared Jul 12, 1999
ETI-EA-G ASSAY
K992191 · LSE
DiaSorin, Inc.
Microbiology · 14d
Cleared Jul 09, 1999
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K990640 · MYI
Id Biomedical Corp.
Microbiology · 133d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · MXJ
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346 · LGC
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 22, 1999
PRONTO DRY
K991248 · LYR
Medical Instruments Corporation Mic AG
Microbiology · 71d
Cleared Jun 17, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983922 · JWY
Dade Microscan, Inc.
Microbiology · 225d