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510(k) K902194

MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1990
Date Received
May 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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  • K911153 — MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (June 18, 1991)

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