Cleared Traditional

TOTAL IRON BINDING CAPACITY TEST

K830032 · Sclavo, Inc. · Chemistry
Jan 1983
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K830032 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY TEST, a Bathophenanthroline, Iron Binding Capacity (Class I — General Controls, product code JQF), submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983, 21 days after receiving the submission on January 7, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K830032 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1983
Decision Date January 28, 1983
Days to Decision 21 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