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510(k) K942958

CREATINE KINASE MB DETERMINATION (UV) by Biochemical Trade, Inc. — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1994
Date Received
June 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Method, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
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  • K905649 — GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (January 30, 1991)
  • K905588 — CREATINE KINASE UV REAGENT SET (January 17, 1991)
  • K871547 — ULTRA-VIOLET BUN REAGENT KIT (RATE) (June 22, 1987)

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