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510(k) K963733

NICCHECK I by Dynagen, Inc. — Product Code MRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1996
Date Received
September 16, 1996
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

Other clearances by Dynagen, Inc.

  • K943050 — MYCOAKT M KANSASII CULTURE ID KIT (March 13, 1995)
  • K943051 — MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (March 13, 1995)
  • K943049 — MYCOAKT M. AVIUM CULTURE ID KIT (March 13, 1995)
  • K931105 — PROCHECK(TM) BLIND PERFORMANCE SPECIMENS (April 21, 1993)
  • K912888 — URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL (February 24, 1992)

Other clearances for product code MRS

  • K030649 — DRI COTININE EIA ASSAY (May 22, 2003)
  • K021688 — NICALERT (October 18, 2002)