VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION— 510(k) K010858

Name: FDA 510(k) clearance K010858
Creator: U.S. Food and Drug Administration
Published: 2001-05-24

Substantially Equivalent

Id Biomedical Corp.

FDA 510(k) clearance K010858 for VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION, Substantially Equivalent on 2001-05-24. Applicant: Id Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Id Biomedical Corp.
Product code: Code MYI
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2001-03-22
Decision date: 2001-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MYI

view all

K140619 — MECA XPRESSFISH2014-10-10
K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST2014-09-03
K121905 — ALERE PBP2A TEST2012-07-26
K090301 — BINAXNOW PBP2A TEST, MODEL 890-0002010-04-14
K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-0002010-02-24

More clearances from Id Biomedical Corp.

view all

K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE2002-05-01
K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY1999-07-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.