Cleared Traditional

IRON/TOTAL IRON BINDING CAPACITY

K901561 · Tech-Co, Inc. · Chemistry
May 1990
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K901561 is an FDA 510(k) clearance for the IRON/TOTAL IRON BINDING CAPACITY, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Tech-Co, Inc. (Rochester Hills, US). The FDA issued a Cleared decision on May 17, 1990, 44 days after receiving the submission on April 3, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K901561 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1990
Decision Date May 17, 1990
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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