Cleared Traditional

WAKO(TM) UIBC

K875176 · Wako Chemicals USA, Inc. · Chemistry
Feb 1988
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K875176 is an FDA 510(k) clearance for the WAKO(TM) UIBC, a Bathophenanthroline, Iron Binding Capacity (Class I — General Controls, product code JQF), submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on February 2, 1988, 47 days after receiving the submission on December 17, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K875176 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1987
Decision Date February 02, 1988
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQF — Bathophenanthroline, Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415

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