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510(k) K880029

EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 by Immuno-Mycologics, Inc. — Product Code KFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1988
Date Received
January 5, 1988
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

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  • K760833 — ANTI-BLASTOMYCES CONTROL SERUM (YEAST) (November 1, 1976)