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510(k) K033745

RAMP TROPONIN I ASSAY by Response Biomedical Corp. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2004
Date Received
December 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Response Biomedical Corp.

  • K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (October 21, 2009)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)
  • K063662 — RAMP NT-PROBNP ASSAY (July 21, 2008)
  • K071591 — RAMP INFLUENZA A/B ASSAY (April 16, 2008)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K012040 — RAMP MYOGLOBIN ASSAY (December 18, 2001)

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