NML CK-MB RIA— 510(k) K812759

Name: FDA 510(k) clearance K812759
Creator: U.S. Food and Drug Administration
Published: 1981-10-19

Substantially Equivalent

Nuclear Medical Laboratories, Inc.

FDA 510(k) clearance K812759 for NML CK-MB RIA, Substantially Equivalent on 1981-10-19. Applicant: Nuclear Medical Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Medical Laboratories, Inc.
Product code: Code JHX
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1981-10-01
Decision date: 1981-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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