ANALYZER, SERUM IRON & TOTAL IRON BINDIN— 510(k) K781009

Name: FDA 510(k) clearance K781009
Creator: U.S. Food and Drug Administration
Published: 1978-07-27

Substantially Equivalent

Environmental Sciences Assoc., Inc.

FDA 510(k) clearance K781009 for ANALYZER, SERUM IRON & TOTAL IRON BINDIN, Substantially Equivalent on 1978-07-27. Applicant: Environmental Sciences Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Environmental Sciences Assoc., Inc.
Product code: Code JMD
Device class: Class 1
Regulation: 21 CFR 862.1275
Advisory panel: Clinical Chemistry
Date received: 1978-06-19
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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