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510(k) K792681

BLASTOMYCES DERMATITIDIS POS/CONTROL by Meridian Diagnostics, Inc. — Product Code KFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Positive Control, Blastomyces Dermatitidis
Device Class
Class II
Regulation Number
866.3060
Review Panel
MI
Submission Type

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Other clearances for product code KFH

  • K880029 — EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (February 24, 1988)
  • K792685 — BLASTOMYCES DERMATITIDIS, ANTISERUM (January 17, 1980)
  • K760833 — ANTI-BLASTOMYCES CONTROL SERUM (YEAST) (November 1, 1976)