IMMUNOSPOT NEONATAL T4 TEST— 510(k) K771606

Name: FDA 510(k) clearance K771606
Creator: U.S. Food and Drug Administration
Published: 1977-09-15

Substantially Equivalent

Meloy Laboratories, Inc.

FDA 510(k) clearance K771606 for IMMUNOSPOT NEONATAL T4 TEST, Substantially Equivalent on 1977-09-15. Applicant: Meloy Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Meloy Laboratories, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1977-08-22
Decision date: 1977-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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