Cleared Traditional

PEG 6,000

K863103 · J. D. Assoc. · Chemistry
Jan 1987
Decision
153d
Days
Class 1
Risk

About This 510(k) Submission

K863103 is an FDA 510(k) clearance for the PEG 6,000, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on January 13, 1987, 153 days after receiving the submission on August 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K863103 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1986
Decision Date January 13, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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