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510(k) K912888

URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL by Dynagen, Inc. — Product Code MIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1992
Date Received
July 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Test Isoniazid
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Dynagen, Inc.

  • K963733 — NICCHECK I (December 13, 1996)
  • 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)

Other clearances for product code MIG

  • K962615 — TUMORLOCALIZER MRI (March 19, 1998)