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510(k) K955814

CEDIA DAU LSD ASSAY by Microgenics Corp. — Product Code DLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1996
Date Received
December 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Lsd (125-I)
Device Class
Class II
Regulation Number
862.3580
Review Panel
TX
Submission Type

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  • K874270 — REVISED LABELING FOR LSD TEST KIT (November 13, 1987)
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