FOLATE/B12 DUO-BEAD RADIOASSAY— 510(k) K822241

Name: FDA 510(k) clearance K822241
Creator: U.S. Food and Drug Administration
Published: 1982-10-26

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K822241 for FOLATE/B12 DUO-BEAD RADIOASSAY, Substantially Equivalent on 1982-10-26. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CEN
Device class: Class 1
Regulation: 21 CFR 862.1550
Advisory panel: Clinical Chemistry
Date received: 1982-07-27
Decision date: 1982-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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