Cleared Traditional

ALBUMIN TEST, HMA ALBUMIN TEST

K771259 · Hycel, Inc. · Chemistry
Aug 1977
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K771259 is an FDA 510(k) clearance for the ALBUMIN TEST, HMA ALBUMIN TEST, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977, 42 days after receiving the submission on July 11, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K771259 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1977
Decision Date August 22, 1977
Days to Decision 42 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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