ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P— 510(k) K952337

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K952337 for ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P, Substantially Equivalent on 1996-02-09. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1995-05-19
Decision date: 1996-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.