ACCESS RED BLOOD CELL FOLATE ASSAY— 510(k) K943149

Name: FDA 510(k) clearance K943149
Creator: U.S. Food and Drug Administration
Published: 1994-08-26

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K943149 for ACCESS RED BLOOD CELL FOLATE ASSAY, Substantially Equivalent on 1994-08-26. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1994-06-30
Decision date: 1994-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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