Cleared Traditional

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

K083339 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Mar 2009
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K083339 is an FDA 510(k) clearance for the DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS), a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 9, 2009, 117 days after receiving the submission on November 12, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K083339 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2008
Decision Date March 09, 2009
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

Similar Devices — CIC Cresolphthalein Complexone, Calcium

All 98
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
K130870 · Hitachi Chemical Diagnostics, Inc. · May 2013
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
K070249 · Horiba Abx · Apr 2007
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
K053401 · Arkray, Inc. · Mar 2006
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
K050077 · Arkray, Inc. · Feb 2005
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
K041009 · Hemagen Diagnostics, Inc. · Jun 2004
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
K023105 · Elan Diagnostics · Mar 2003