B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644— 510(k) K093631

Name: FDA 510(k) clearance K093631
Creator: U.S. Food and Drug Administration
Published: 2010-02-12

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K093631 for B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644, Substantially Equivalent on 2010-02-12. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Product code CDD
Device class: Class 2
Regulation: 21 CFR 862.1810
Advisory panel: Clinical Chemistry
Date received: 2009-11-24
Decision date: 2010-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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