RIANEN ASSAY SYSTEM, 125I KIT— 510(k) K781495

Name: FDA 510(k) clearance K781495
Creator: U.S. Food and Drug Administration
Published: 1978-09-14

Substantially Equivalent

New England Nuclear

FDA 510(k) clearance K781495 for RIANEN ASSAY SYSTEM, 125I KIT, Substantially Equivalent on 1978-09-14. Applicant: New England Nuclear. Device class: 2.

Clearance details

Applicant: New England Nuclear
Product code: Code DNL
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1978-08-30
Decision date: 1978-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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