Cleared Traditional

COMBO-FER IRON DIAGNOSTIC

K811954 · Immuno Assay Corp. · Chemistry
Jul 1981
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K811954 is an FDA 510(k) clearance for the COMBO-FER IRON DIAGNOSTIC, a Radiometric, Fe59, Iron Binding Capacity (Class I — General Controls, product code JQG), submitted by Immuno Assay Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981, 19 days after receiving the submission on July 8, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K811954 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1981
Decision Date July 27, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQG — Radiometric, Fe59, Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415