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510(k) K810861

CREATINE KINASE MB ISOENZYME IMMUNO UV by The Dow Chemical Co. — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1981
Date Received
March 31, 1981
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

Other clearances by The Dow Chemical Co.

  • K823474 — ENZYMATIC GLUCOSE DETERMINATION (December 30, 1982)
  • K822154 — UREA NITROGEN (ENZYMATIC) DETERMINATION (August 5, 1982)
  • K821536 — DOWFLOW ALT-UV DETERMINATION (June 14, 1982)
  • K821315 — DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM (May 24, 1982)
  • K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS (April 1, 1982)
  • K820714 — DOW BILIRUBIN(DIRECT) DETERMINATION (April 1, 1982)
  • K812777 — DIRECT IRON REAGENT SET (October 19, 1981)
  • K811806 — QUICK-CHEM COLORIMETER (July 15, 1981)
  • K810727 — AST-UV (PLP-ACTIVATED) DETERMINATION (March 31, 1981)
  • K801501 — UV URIC ACID STANDARDS (September 26, 1980)

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  • K944325 — LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (February 22, 1995)
  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K935924 — AXSYM CK-MB (June 21, 1994)