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510(k) K790309

CPK ISOENZYME SUBSTRATE by Electrophoresis Corp. — Product Code JHY

K790309 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. for the device "CPK ISOENZYME SUBSTRATE". The FDA issued a decision of Substantially Equivalent on April 4, 1979. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Electrophoresis Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1979
Date Received
February 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Electrophoresis Corp.

  • K802395 — SPECIAL PROCEDURE AQAROSE FILM (November 26, 1980)
  • K790311 — LDH ISOENZYME REAGENT (March 21, 1979)
  • K790310 — HEMOGLOBIN CONTROLS (March 21, 1979)

Other clearances for product code JHY

  • K143720 — Dimension Vista MMB Assay (September 18, 2015)
  • K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CR (May 13, 2014)
  • K140404 — ELECSYS CK-MB STAT IMMUNOASSAY (May 8, 2014)
  • K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (October 18, 2013)
  • K070835 — OLYMPUS CK-MB REAGENT (June 4, 2007)
  • K022757 — SPIFE CK KIT, MODEL 3332, 3333 (October 11, 2002)
  • K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (August 29, 2002)
  • K974421 — ELECSYS CK-MB STAT (December 17, 1997)
  • K970343 — MMB METHOD (February 14, 1997)
  • K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (June 18, 1996)

FDA data resources