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510(k) K030649

DRI COTININE EIA ASSAY by Microgenics Corp. — Product Code MRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2003
Date Received
February 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test System, Nicotine, Cotinine, Metabolites
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

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  • K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (April 8, 2011)
  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)

Other clearances for product code MRS

  • K021688 — NICALERT (October 18, 2002)
  • K963733 — NICCHECK I (December 13, 1996)