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510(k) K890295

TARGET(TM) CK-MB by V-Tech, Inc. — Product Code JHY

K890295 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET(TM) CK-MB". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
January 19, 1989
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 V-Tech, Inc.

  • K914303 — TARGET(TM)-HOG (October 11, 1991)
  • K910892 — TARGET(TM) CANNABINOIDS-V TEST (April 3, 1991)
  • K910893 — TARGET(TM) CANNABINOIDS-R TEST (April 3, 1991)
  • K910739 — TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (March 21, 1991)
  • K910738 — TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (March 19, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K903937 — TARGET(TM) HOG ONE STEP (October 22, 1990)
  • K890978 — TARGET OPIATES-R (November 17, 1989)
  • K890979 — TARGET OPIATES-V (October 4, 1989)

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