Cleared Traditional

J & S IRON SATURATING REAGENT

K811942 · Thyroid Diagnostics, Inc. · Toxicology
Sep 1981
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K811942 is an FDA 510(k) clearance for the J & S IRON SATURATING REAGENT, a Bathophenanthroline, Iron Binding Capacity (Class I — General Controls, product code JQF), submitted by Thyroid Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981, 63 days after receiving the submission on July 7, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K811942 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1981
Decision Date September 08, 1981
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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