Cleared Traditional

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

K122323 · Siemens Healthcare Diagnostics · Chemistry

Aug 2012

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K122323 is an FDA 510(k) clearance for the DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI, a Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJO), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on August 28, 2012, 27 days after receiving the submission on August 1, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K122323 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2012
Decision Date	August 28, 2012
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	CJO — Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1050