HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS— 510(k) K955087

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K955087 for HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS, Substantially Equivalent on 1996-06-13. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1995-11-07
Decision date: 1996-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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