Cleared Traditional

K863050 - ALBUMETER
(FDA 510(k) Clearance)

K863050 · J. D. Assoc. · Chemistry
Sep 1986
Decision
30d
Days
Class 2
Risk

K863050 is an FDA 510(k) clearance for the ALBUMETER. This device is classified as a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX).

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 FDA review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K863050 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 CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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