PARAGON ELECTRO. CREATINE KINASE TEST KI— 510(k) K802826

Name: FDA 510(k) clearance K802826
Creator: U.S. Food and Drug Administration
Published: 1981-01-09

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K802826 for PARAGON ELECTRO. CREATINE KINASE TEST KI, Substantially Equivalent on 1981-01-09. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JHX
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1980-11-10
Decision date: 1981-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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