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510(k) K880705

THERAPEUTIC DRUG STANDARD by Verichem Laboratories, Inc. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
February 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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