DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR— 510(k) K121907

Name: FDA 510(k) clearance K121907
Creator: U.S. Food and Drug Administration
Published: 2012-07-23

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K121907 for DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR, Substantially Equivalent on 2012-07-23. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code CJO
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2012-06-29
Decision date: 2012-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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