B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K964791

Name: FDA 510(k) clearance K964791
Creator: U.S. Food and Drug Administration
Published: 1997-05-29

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K964791 for B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1997-05-29. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code JZG
Device class: Class 2
Regulation: 21 CFR 866.5630
Advisory panel: Immunology
Date received: 1996-11-29
Decision date: 1997-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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