TARGET(TM) CK-MB— 510(k) K890295

Substantially Equivalent

V-Tech, Inc.

FDA 510(k) clearance K890295 for TARGET(TM) CK-MB, Substantially Equivalent on 1989-08-15. Applicant: V-Tech, Inc.. Device class: 2.

Clearance details

Applicant: V-Tech, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1989-01-19
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Monte, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHY

K143720 — Dimension Vista MMB Assay2015-09-18
K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL2014-05-13
K140404 — ELECSYS CK-MB STAT IMMUNOASSAY2014-05-08
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY2013-10-18
K070835 — OLYMPUS CK-MB REAGENT2007-06-04

More clearances from V-Tech, Inc.

K914303 — TARGET(TM)-HOG1991-10-11
K910892 — TARGET(TM) CANNABINOIDS-V TEST1991-04-03
K910893 — TARGET(TM) CANNABINOIDS-R TEST1991-04-03
K910739 — TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)1991-03-21
K910122 — TARGET COCAINE METABOLITE-R1991-03-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.