FDA 510(k) Applications Submitted by Debra Hutson

FDA 510(k) Number Submission Date Device Name Applicant
K100525 02/24/2010 ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 SEPPIM S.A.S.
K100263 01/28/2010 ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS SEPPIM S.A.S.
K100547 02/25/2010 ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL SEPPIM S.A.S.
K130765 03/20/2013 ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II ELITECHGROUP
K110780 03/21/2011 ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II ELITECH GROUP
K110830 03/25/2011 ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH ELITECHGROUP
K141265 05/15/2014 ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT ELITECHGROUP
K111960 07/11/2011 ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS ELITECHGROUP
K111996 07/13/2011 ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 ELITECHGROUP
K112029 07/15/2011 ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 ELITECHGROUP
K122083 07/16/2012 ELITECH CLINICAL SYSTEMS CK NAC SL ELITECHGROUP
K122177 07/23/2012 ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL ELITECHGROUP
K132399 08/01/2013 ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL ELITECH GROUP
K132468 08/07/2013 MRSA/SA ELITE MGB, ELITE MGB SOFTWARE ELITechGroup Epoch Biosciences
K102647 09/14/2010 ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... ELITECHGROUP VITAL SCIENTIFIC BV
K122858 09/18/2012 ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II ELITECHGROUP
K112937 10/03/2011 MRSA/SA ELITE MGB ELITECH
K102993 10/08/2010 ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL SEPPIM S.A.S.
K113269 11/04/2011 ELITTECH CLINICAL SYSTEMS ALP IFCC SL ELITECHGROUP
K103376 11/17/2010 ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL SEPPIM S.A.S.
K093883 12/18/2009 AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- SEPPIM S.A.S.
K103747 12/23/2010 ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS ELITECHGROUP SEPPIM S.A.S.


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