Cleared Traditional

CPK (UV) REAGENT KIT

K855188 · Technostics Intl. · Chemistry
Mar 1986
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K855188 is an FDA 510(k) clearance for the CPK (UV) REAGENT KIT, a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on March 5, 1986, 69 days after receiving the submission on December 26, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K855188 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1985
Decision Date March 05, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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