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510(k) K931105

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS by Dynagen, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1993
Date Received
March 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Dynagen, Inc.

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  • K943051 — MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (March 13, 1995)
  • K943049 — MYCOAKT M. AVIUM CULTURE ID KIT (March 13, 1995)
  • K912888 — URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL (February 24, 1992)

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