Cleared Traditional

TARGET(TM) CK-MB

K890295 · V-Tech, Inc. · Chemistry
Aug 1989
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K890295 is an FDA 510(k) clearance for the TARGET(TM) CK-MB, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on August 15, 1989, 208 days after receiving the submission on January 19, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K890295 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1989
Decision Date August 15, 1989
Days to Decision 208 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHY — Colorimetric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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