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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