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510(k) K790400

URINE NEGATIVE CALIBRATOR by Syva Co. — Product Code DLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1979
Date Received
February 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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