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510(k) K782156

UNITEST CREATINE KINASE by Boehringer Mannheim Corp. — Product Code JLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1979
Date Received
December 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atp And Creatine Kinase (Enzymatic), Creatine
Device Class
Class I
Regulation Number
862.1210
Review Panel
CH
Submission Type

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Other clearances for product code JLB

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