Cleared Traditional

COLORIMETRIC CHLORIDE PRODUCT #4314125

K900827 · American Research Products Co. · Chemistry
May 1990
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K900827 is an FDA 510(k) clearance for the COLORIMETRIC CHLORIDE PRODUCT #4314125, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on May 2, 1990, 70 days after receiving the submission on February 21, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K900827 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1990
Decision Date May 02, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHI — Lipase-esterase, Enzymatic, Photometric, Lipase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1465

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