CREATINE KINASE MB ENZYME IMMUNOASSAY KIT— 510(k) K884550

Name: FDA 510(k) clearance K884550
Creator: U.S. Food and Drug Administration
Published: 1989-02-23

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K884550 for CREATINE KINASE MB ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1989-02-23. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1988-10-31
Decision date: 1989-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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