Cleared Traditional

ANALYZER, SERUM IRON & TOTAL IRON BINDIN

K781009 · Environmental Sciences Assoc., Inc. · Chemistry
Jul 1978
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K781009 is an FDA 510(k) clearance for the ANALYZER, SERUM IRON & TOTAL IRON BINDIN, a Radioimmunoassay, Total Estrogens, Nonpregnancy (Class I — General Controls, product code JMD), submitted by Environmental Sciences Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 38 days after receiving the submission on June 19, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1275.

Submission Details

510(k) Number K781009 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1978
Decision Date July 27, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JMD — Radioimmunoassay, Total Estrogens, Nonpregnancy
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1275