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510(k) K810853

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT by The Upjohn Co. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1981
Date Received
March 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by The Upjohn Co.

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  • K780792 — TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (June 13, 1978)
  • K760920 — CAT-A-KIT (November 9, 1976)

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