C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C— 510(k) K052101

Name: FDA 510(k) clearance K052101
Creator: U.S. Food and Drug Administration
Published: 2005-08-26

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K052101 for C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C, Substantially Equivalent on 2005-08-26. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 2005-08-03
Decision date: 2005-08-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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