Cleared Traditional

TOTAL IRON BINDING CAPACITY

K780412 · Diagnostic Corp. of America · Chemistry
May 1978
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K780412 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY, a Radiometric, Fe59, Iron Binding Capacity (Class I — General Controls, product code JQG), submitted by Diagnostic Corp. of America (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978, 72 days after receiving the submission on March 15, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K780412 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1978
Decision Date May 26, 1978
Days to Decision 72 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