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510(k) K810861

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

K810861 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "CREATINE KINASE MB ISOENZYME IMMUNO UV". The FDA issued a decision of Substantially Equivalent on April 14, 1981. The device falls under product code JHW (U.V. Method, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code JHW

  • K162526 — Creatine Kinase-MB (May 26, 2017)
  • K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (July 18, 2014)
  • K122083 — ELITECH CLINICAL SYSTEMS CK NAC SL (August 22, 2012)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K003158 — ROCHE DIAGNOSTICS CK-MB (December 18, 2000)
  • K961501 — ELECSYS CK-MB (June 11, 1996)
  • K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (March 13, 1995)
  • 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)

FDA data resources