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510(k) K921939

SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) by Heraeus Kulzer, Inc. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1992
Date Received
April 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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