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510(k) K010858

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION by Id Biomedical Corp. — Product Code MYI

K010858 is an FDA 510(k) premarket notification submitted by Id Biomedical Corp. for the device "VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION". The FDA issued a decision of Substantially Equivalent on May 24, 2001. The device falls under product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies), a Class II device regulated under 21 CFR 866.1640. Id Biomedical Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2001
Date Received
March 22, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Id Biomedical Corp.

  • K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (May 1, 2002)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)

Other clearances for product code MYI

  • K140619 — MECA XPRESSFISH (October 10, 2014)
  • K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST (September 3, 2014)
  • K121905 — ALERE PBP2A TEST (July 26, 2012)
  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
  • K062864 — MASTALEX -MRSA, MODEL RST501 (October 18, 2006)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K011400 — MRSA-SCREEN (March 27, 2002)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)

FDA data resources