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510(k) K802427

LA-SPORO ANTIBODY SYSTEM by Immuno-Mycologics, Inc. — Product Code GMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Sporothrix Schenekii
Device Class
Class I
Regulation Number
866.3680
Review Panel
MI
Submission Type

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