Cleared Traditional

AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT

K860661 · Amresco, Inc. · Chemistry
Mar 1986
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K860661 is an FDA 510(k) clearance for the AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on March 14, 1986, 18 days after receiving the submission on February 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K860661 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1986
Decision Date March 14, 1986
Days to Decision 18 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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