Cleared Traditional

ALBUMIN, BROMCRESOL GREEN DYE-BINDING

K875070 · Tech-Co, Inc. · Chemistry
Jan 1988
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K875070 is an FDA 510(k) clearance for the ALBUMIN, BROMCRESOL GREEN DYE-BINDING, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on January 11, 1988, 33 days after receiving the submission on December 9, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K875070 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1987
Decision Date January 11, 1988
Days to Decision 33 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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