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510(k) K943050

MYCOAKT M KANSASII CULTURE ID KIT by Dynagen, Inc. — Product Code JSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1995
Date Received
June 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Mycobacteria
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Dynagen, Inc.

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

  • K943051 — MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (March 13, 1995)
  • K943049 — MYCOAKT M. AVIUM CULTURE ID KIT (March 13, 1995)
  • K880990 — ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION (March 24, 1988)
  • K830211 — API TB-IDENT* (March 24, 1983)