DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI— 510(k) K122323

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

2012-08-01

Decision date

2012-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Newark, DE, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122323.