VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873— 510(k) K052645

Name: FDA 510(k) clearance K052645
Creator: U.S. Food and Drug Administration
Published: 2005-12-14

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K052645 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873, Substantially Equivalent on 2005-12-14. Applicant: Ortho-Clinical Diagnostics. Device class: 1.

Clearance details

Device name as filed: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
Applicant: Ortho-Clinical Diagnostics
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 2005-09-26
Decision date: 2005-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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