Cleared Traditional

CHOLESTECH BUN/CREATININE TEST SYSTEM

K972012 · Cholestech Corp. · Chemistry
Jul 1997
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K972012 is an FDA 510(k) clearance for the CHOLESTECH BUN/CREATININE TEST SYSTEM, a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on July 24, 1997, 55 days after receiving the submission on May 30, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K972012 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 1997
Decision Date July 24, 1997
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDN — Urease, Photometric, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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