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510(k) K812472

SPIN-CHEM LD-L REAGENT by Smithkline Diagnostics, Inc. — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1981
Date Received
August 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

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  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)

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