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510(k) K070835

OLYMPUS CK-MB REAGENT by Olympus Life & Material Science Europa GmbH (Irish — Product Code JHY

K070835 is an FDA 510(k) premarket notification submitted by Olympus Life & Material Science Europa GmbH (Irish for the device "OLYMPUS CK-MB REAGENT". The FDA issued a decision of Substantially Equivalent on June 4, 2007. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Olympus Life & Material Science Europa GmbH (Irish has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2007
Date Received
March 27, 2007
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 Olympus Life & Material Science Europa GmbH (Irish

  • K070708 — OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR2 (August 21, 2007)
  • K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR30 (June 11, 2007)

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)
  • 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)
  • K951638 — AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (May 2, 1995)

FDA data resources