Cleared Traditional

CHOLESTEROL-E (FREE)

K863064 · J. D. Assoc. · Chemistry
Sep 1986
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K863064 is an FDA 510(k) clearance for the CHOLESTEROL-E (FREE), 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 September 11, 1986, 30 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K863064 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date September 11, 1986
Days to Decision 30 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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