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510(k) K980012

CREATINE KINASE REAGENT by Ac Biochemicals, Inc. — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1998
Date Received
January 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Ac Biochemicals, Inc.

  • K982539 — HDLC PRECIPITATING REAGENT (September 15, 1998)
  • K980013 — AMYLASE (February 4, 1998)

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