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510(k) K011400

MRSA-SCREEN by Denka Seiken'S — Product Code MYI

K011400 is an FDA 510(k) premarket notification submitted by Denka Seiken'S for the device "MRSA-SCREEN". The FDA issued a decision of Substantially Equivalent on March 27, 2002. 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. Denka Seiken'S has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2002
Date Received
May 7, 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 Denka Seiken'S

  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)
  • K011958 — CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT (December 4, 2001)
  • K981734 — VTEC-RPLA SEIKEN (September 22, 1998)

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)
  • K010858 — VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (May 24, 2001)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)

FDA data resources