HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL— 510(k) K063209

Substantially Equivalent

Thermo Electron OY

FDA 510(k) clearance K063209 for HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL, Substantially Equivalent on 2007-03-21. Applicant: Thermo Electron OY.

Clearance details

Applicant: Thermo Electron OY
Product code: Code LCP
Advisory panel: Hematology
Date received: 2006-10-23
Decision date: 2007-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

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