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510(k) K811694

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT by Baker Instructions Corp. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

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