Cleared Traditional

AMMONIA/IRON STANDARD KIT

K972333 · Verichem Laboratories, Inc. · Chemistry
Jul 1997
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K972333 is an FDA 510(k) clearance for the AMMONIA/IRON STANDARD KIT, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on July 23, 1997, 30 days after receiving the submission on June 23, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K972333 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1997
Decision Date July 23, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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