Target(Tm) Ck-Mb

FDA 510(k) K890295 · V-Tech, Inc.

Substantially Equivalent

510(k) numberK890295

Submission

Device name
Target(Tm) Ck-Mb
Applicant
V-Tech, Inc.
El Monte, CA, US
Received
January 19, 1989
Decision date
August 15, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JHY – Colorimetric Method, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

Other 510(k)s with product code JHY

510(k)DeviceApplicantDecision
K143720Dimension Vista MMB AssayJHY · Traditional Siemens Healthcare Diagnostics09/18/2015SE
K130080Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional Medica Corporation05/13/2014SE
K140404Elecsys Ck-Mb Stat ImmunoassayJHY · Special Roche Diagnostics05/08/2014SE
K132571Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional Roche Diagnostics10/18/2013SE
K070835Olympus Ck-Mb ReagentJHY · Traditional Olympus Life & Material Science Europa GmbH (Irish06/04/2007SE
K022757Spife CK Kit, Model 3332, 3333JHY · Traditional Helena Laboratories10/11/2002SE
K022654Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special Roche Diagnostics Corp.08/29/2002SE
K974421Elecsys Ck-Mb StatJHY · Traditional Boehringer Mannheim Corp.12/17/1997SE
K970343MMB MethodJHY · Traditional Dade Chemistry Systems, Inc.02/14/1997SE
K961412Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional Bayer Corp.06/18/1996SE

More from Bayer Corp.

510(k)DeviceDecision
K914303Target(Tm)-HogJHI · Traditional 10/11/1991SE
K910893Target(Tm) Cannabinoids-R TestLDJ · Traditional 04/03/1991SE
K910892Target(Tm) Cannabinoids-V TestLDJ · Traditional 04/03/1991SE
K910739Target Amphetamine/Methamphetamine-R (Reader Meth)DKZ · Traditional 03/21/1991SE
K910738Target Amphetamine/Methamphetamine-V (Visual Meth)DKZ · Traditional 03/19/1991SE
K910123Target Cocaine Metabolite-VKLN · Traditional 03/19/1991SE
K910122Target Cocaine Metabolite-RKLN · Traditional 03/19/1991SE
K903937Target(Tm) Hog One StepJHI · Traditional 10/22/1990SE
K890978Target Opiates-RDJG · Traditional 11/17/1989SE
K890979Target Opiates-VDJG · Traditional 10/04/1989SE

Questions and answers

When was Target(Tm) Ck-Mb cleared by the FDA?

Target(Tm) Ck-Mb (K890295) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 208 days after the submission was received.

What is the product code of K890295?

The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.