FDA 510(k) Applications Submitted by Gary Lehnus

FDA 510(k) Number Submission Date Device Name Applicant
K120169 01/19/2012 INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT GRIFOLS USA, LLC
K040146 01/22/2004 INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM INTERLAB S.R.L.
K010289 01/31/2001 SCIMEDX PHASE II MPO IGG ANTIBODY EIA SCIMEDX CORP.
K010287 01/31/2001 SCIMEDX PHASE II PR3 IGG ANTIBODY EIA SCIMEDX CORP.
K110309 02/02/2011 FOB ONE STEP RAPID TEST ORIENT GENE BIOTECH
DEN110001 02/16/2011 RIDASCREEN NOROVIRUS 3RD GENERATION EIA R-Biopharm AG
K100499 02/22/2010 ORGENTEC RHEUMATOID FACTOR EIA ORGENTEC DIAGNOSTIKA GMBH
K010625 03/02/2001 EUROSPITAL EU-TTG IGA UMANA SCIMEDX CORP.
K040923 04/08/2004 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA IBL GMBH
K011082 04/10/2001 TPO IGG ANTIBODY EIA TEST SCIMEDX CORP.
K971502 04/24/1997 SERODIA TP-PA SCIMEDX TEKFILE SERVICES
K011348 05/02/2001 PHASE II GBM IGG ANTIBODY EIA TEST SCIMEDX CORP.
K051144 05/04/2005 ACETYLCHOLINE RECEPTOR AB (ARAB)RRA IBL-HAMBURG GMBH
K001552 05/18/2000 TREPCHEK TREPONEMAL ANTIBODY EIA PHOENIX BIOTECH CORP.
K091468 05/18/2009 IVD TECHNOLOGIES ACHRAB TEST KIT IVD TECHNOLOGIES
K041349 05/20/2004 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM IBL GMBH
K962360 06/19/1996 IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES SCIMEDX CORP.
K051733 06/28/2005 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL DRG INTL., INC.
K041871 07/09/2004 INTERLAB MICROCAL SERUM CONTROLS TROUBLE SHOOTER CONSULING, INC.
K002169 07/18/2000 GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM SCIMEDX CORP.
K051969 07/20/2005 TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA IBL GMBH
K032254 07/22/2003 IBL C1Q-CIC CIA TEST IBL GMBH
K062120 07/25/2006 CISBIO RENIN RIA TEST CIS BIO INTERNATIONAL
K112126 07/25/2011 GENUINE FIRST AID CPR MASK GENUINE FIRST AID LLC
K092399 08/06/2009 ANTI-MUTATED CITRULLINATED VIMENTIN EIA ORGENTEC DIAGNOSTIKA GMBH
K002450 08/09/2000 GENUA MENOPAUSE MONITOR TEST KIT GENUA 1944, INC.
K102299 08/13/2010 CPR FACE MASK GENUINE FIRST AID LLC
K102400 08/24/2010 SYPHILIS HEALTH CHECK DIAGNOSTICS DIRECT, LLC.
K052359 08/26/2005 IBL CORTISOL LIA TEST KIT Lehnus & Associates Consulting
K062534 08/29/2006 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE DRG INTL., INC.
K032796 09/08/2003 IBL C3D-CIC EIA TEST IBL GMBH
K032862 09/12/2003 INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM INTERLAB S.R.L.
K052649 09/26/2005 DRG SLV TESTOSTERONE ELISA TEST DRG INTL., INC.
K062981 09/29/2006 I-CHROMA CRP TEST BODITECH DIAGNOSTICS, INC.
K033187 10/01/2003 INTERLAB IMMUNOFIXATION TEST(S) INTERLAB S.R.L.
K072836 10/03/2007 CHOLESTRAK HDL CHOLESTEROL HOME TEST ACCUTECH, LLC.
K955085 10/26/1995 HM-CAP EIA TEST (MODIFICATION) SCHIFF & CO.
K954926 10/26/1995 HM-CAP CONTROL PANEL E-Z-EM, INC.
K033786 12/04/2003 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA IBL GMBH
K103574 12/06/2010 PREGNANCY ONE STEP RAPID TEST Lehnus & Associates Consulting
K053571 12/22/2005 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM INTERLAB S.R.L.
K053570 12/22/2005 TREP-SURE TREPONEMAL ANTIBODY EIA PHOENIX BIOTECH CORP.
K103757 12/23/2010 IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT GRIFOLS
K994379 12/27/1999 EU-TTG IGA ELISA SCIMEDX CORP.
K970198 01/21/1997 IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES SCIMEDX CORP.
K002107 07/12/2000 IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. SCIMEDX CORP.


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