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510(k) K905588

CREATINE KINASE UV REAGENT SET by Biochemical Trade, Inc. — Product Code JHW

K905588 is an FDA 510(k) premarket notification submitted by Biochemical Trade, Inc. for the device "CREATINE KINASE UV REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 17, 1991. The device falls under product code JHW (U.V. Method, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Biochemical Trade, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1991
Date Received
December 13, 1990
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 Biochemical Trade, Inc.

  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K910635 — TOTAL BILIRUBIN REAGENT SET (May 15, 1991)
  • K910296 — PHOSPHORUS (INORGANIC) TEST SYSTEM (February 27, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K905790 — TOTAL PROTEIN REAGENT SET (February 21, 1991)
  • K905650 — KINETIC ALKALINE PHOSPHATASE DETERMINATION (February 13, 1991)
  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
  • K905651 — KINETIC AMYLASE DETERMINATION (January 31, 1991)
  • K905649 — GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (January 30, 1991)
  • K871547 — ULTRA-VIOLET BUN REAGENT KIT (RATE) (June 22, 1987)

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