Cleared Traditional

DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR

K121907 · Siemens Healthcare Diagnostics · Chemistry

Jul 2012

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K121907 is an FDA 510(k) clearance for the DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR, 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 July 23, 2012, 24 days after receiving the submission on June 29, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K121907 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2012
Decision Date	July 23, 2012
Days to Decision	24 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