Cleared Traditional

CHEMISTRY ANALYZER REAGENTS

K792482 · Laboratory Products, Inc. · Chemistry
Jan 1980
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K792482 is an FDA 510(k) clearance for the CHEMISTRY ANALYZER REAGENTS, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980, 53 days after receiving the submission on November 19, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K792482 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1979
Decision Date January 11, 1980
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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