Cleared Traditional

STAT PROFILE M7 ANALYZER

K991727 · Nova Biomedical Corp. · Chemistry
Jul 1999
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K991727 is an FDA 510(k) clearance for the STAT PROFILE M7 ANALYZER, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on July 16, 1999, 57 days after receiving the submission on May 20, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K991727 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1999
Decision Date July 16, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGL — Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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