FDA 510(k) Applications Submitted by EDWARD M LEVINE

FDA 510(k) Number Submission Date Device Name Applicant
K033234 10/06/2003 IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER DIAGNOSTIC PRODUCTS CORP.
K000005 01/03/2000 IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 DIAGNOSTIC PRODUCTS CORP.
K000006 01/03/2000 IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 DIAGNOSTIC PRODUCTS CORP.
K000007 01/03/2000 IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 DIAGNOSTIC PRODUCTS CORP.
K000012 01/03/2000 IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 DIAGNOSTIC PRODUCTS CORP.
K960154 01/16/1996 PSA CONTROLS DIAGNOSTIC PRODUCTS CORP.
K990222 01/25/1999 IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 DIAGNOSTIC PRODUCTS CORP.
K000257 01/27/2000 IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 DIAGNOSTIC PRODUCTS CORP.
K000463 02/11/2000 IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG DIAGNOSTIC PRODUCTS CORP.
K980833 03/04/1998 IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 DIAGNOSTIC PRODUCTS CORP.
K970877 03/10/1997 IMMULITE CEA DIAGNOSTIC PRODUCTS CORP.
K990886 03/17/1999 IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 DIAGNOSTIC PRODUCTS CORP.
K010878 03/19/2001 MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 DIAGNOSTIC PRODUCTS CORP.
K971051 03/24/1997 IMMULITE THYROID AUTOANTIBODY CONTROL MODULE DIAGNOSTIC PRODUCTS CORP.
K971177 03/31/1997 IMMULITE VITAMIN B12 (LKVB1,LKVB5) DIAGNOSTIC PRODUCTS CORP.
K991096 04/01/1999 IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 DIAGNOSTIC PRODUCTS CORP.
K991094 04/01/1999 IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 DIAGNOSTIC PRODUCTS CORP.
K981297 04/08/1998 IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 DIAGNOSTIC PRODUCTS CORP.
K971312 04/09/1997 IMMULITE PYRILINKS-D DIAGNOSTIC PRODUCTS CORP.
K991277 04/14/1999 MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 DIAGNOSTIC PRODUCTS CORP.
K021257 04/19/2002 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) DIAGNOSTIC PRODUCTS CORP.
K981455 04/23/1998 THIRD GENERATION PSA CONTROL MODULE DIAGNOSTIC PRODUCTS CORP.
K981495 04/27/1998 IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP.
K971792 05/15/1997 IMMULITE FREE T4 (2-STEP) DIAGNOSTIC PRODUCTS CORP.
K961889 05/16/1996 SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS DIAGNOSTIC PRODUCTS CORP.
K011505 05/16/2001 IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 DIAGNOSTIC PRODUCTS CORP.
K991795 05/26/1999 IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 DIAGNOSTIC PRODUCTS CORP.
K991796 05/26/1999 IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 DIAGNOSTIC PRODUCTS CORP.
K991797 05/26/1999 IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 DIAGNOSTIC PRODUCTS CORP.
K972021 06/02/1997 IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) DIAGNOSTIC PRODUCTS CORP.
K982078 06/15/1998 IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP.
K962323 06/17/1996 IMMULITE OPIATES SCREEN/CONTROL MODULE DIAGNOSTIC PRODUCTS CORP.
K992105 06/22/1999 IMMULITE TURBO INTACT PTH, MODEL LSKPTZ DIAGNOSTIC PRODUCTS CORP.
K022118 07/01/2002 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP.
K012075 07/02/2001 IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 DIAGNOSTIC PRODUCTS CORP.
K012077 07/02/2001 IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 DIAGNOSTIC PRODUCTS CORP.
K982466 07/15/1998 IMMULITE THYROGLOBULIN MODEL LKTY DIAGNOSTIC PRODUCTS CORP.
K982468 07/15/1998 IMMULITE 2000 THYROGLOBULIN MODEL L2KTY DIAGNOSTIC PRODUCTS CORP.
K982473 07/16/1998 TUMOR MARKER CONTROL DIAGNOSTIC PRODUCTS CORP.
K012301 07/20/2001 IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP.
K012312 07/23/2001 IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP.
K012311 07/23/2001 IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP.
K962936 07/29/1996 IMMULITE TOXOPLASMA QUANTITATIVE IGG DIAGNOSTIC PRODUCTS CORP.
K982637 07/29/1998 IMMULITE PSA CONTROL MODULE, MODEL LPSCM DIAGNOSTIC PRODUCTS CORP.
K992632 08/06/1999 IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 DIAGNOSTIC PRODUCTS CORP.
K992634 08/06/1999 IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 DIAGNOSTIC PRODUCTS CORP.
K022603 08/06/2002 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER DIAGNOSTIC PRODUCTS CORP.
K963245 08/19/1996 IMMULITE LATEX-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP.
K963613 09/10/1996 IMMULITE RUBELLA IGG DIAGNOSTIC PRODUCTS CORP.
K983203 09/14/1998 IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 DIAGNOSTIC PRODUCTS CORP.
K032881 09/15/2003 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE DIAGNOSTIC PRODUCTS CORP.
K983263 09/17/1998 IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 DIAGNOSTIC PRODUCTS CORP.
K013135 09/19/2001 IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP.
K983336 09/23/1998 PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 DIAGNOSTIC PRODUCTS CORP.
K023152 09/23/2002 IMMULITE 2000 ALLERGEN-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP.
K983391 09/25/1998 IMMULITE 2000 OM-MA MODEL L2KOP2 DIAGNOSTIC PRODUCTS CORP.
K993251 09/28/1999 IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 DIAGNOSTIC PRODUCTS CORP.
K993254 09/28/1999 IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 DIAGNOSTIC PRODUCTS CORP.
K023304 10/03/2002 IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL DIAGNOSTIC PRODUCTS CORP.
K013566 10/26/2001 IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 DIAGNOSTIC PRODUCTS CORP.
K983954 11/05/1998 ALASTAT MICROPLATE MIXED ALLERGEN PANELS DIAGNOSTIC PRODUCTS CORP.
K983970 11/09/1998 IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 DIAGNOSTIC PRODUCTS CORP.
K983971 11/09/1998 CARDIAC MARKER CONTROL MODULE, MODEL CCCM DIAGNOSTIC PRODUCTS CORP.
K983972 11/09/1998 IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 DIAGNOSTIC PRODUCTS CORP.
K984132 11/18/1998 IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 DIAGNOSTIC PRODUCTS CORP.
K003597 11/21/2000 IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 DIAGNOSTIC PRODUCTS CORP.
K993952 11/22/1999 IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 DIAGNOSTIC PRODUCTS CORP.
K955376 11/24/1995 IMMULITE HGH DIAGNOSTIC PRODUCTS CORP.
K994085 12/03/1999 IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 DIAGNOSTIC PRODUCTS CORP.
K013984 12/03/2001 IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR DIAGNOSTIC PRODUCTS CORP.
K974634 12/12/1997 IMMULITE FREE T3 DIAGNOSTIC PRODUCTS CORP.
K965114 12/20/1996 TUMOR MARKER CONTROL DIAGNOSTIC PRODUCTS CORP.
K965103 12/20/1996 WINMAX SOFTWARE SYSTEMS DIAGNOSTIC PRODUCTS CORP.
K004002 12/26/2000 IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) DIAGNOSTIC PRODUCTS CORP.
K955870 12/28/1995 IMMULITE TOTAL TESTOSTERONE DIAGNOSTIC PRODUCTS CORP.
K973186 08/25/1997 IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP.
K960067 01/05/1996 IMMILITE TOTAL IGE DIAGNOSTIC PRODUCTS CORP.
K980206 01/20/1998 IMMULITE ANTI-TG AB DIAGNOSTIC PRODUCTS CORP.
K962975 07/31/1996 PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) DIAGNOSTIC PRODUCTS CORP.
K963240 08/19/1996 IMMULITE ACTH CONTROL MODULE (LACCM) DIAGNOSTIC PRODUCTS CORP.
K963695 09/16/1996 IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ DIAGNOSTIC PRODUCTS CORP.
K963918 09/30/1996 IMMULITE COCAINE METABOLITE DIAGNOSTIC PRODUCTS CORP.
K963916 09/30/1996 IMMULITE CANNABINOIDS DIAGNOSTIC PRODUCTS CORP.
K034055 12/30/2003 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I DIAGNOSTIC PRODUCTS CORP.
K960066 01/05/1996 IMMULITE ACTH DIAGNOSTIC PRODUCTS CORP.
K013134 09/19/2001 IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP.
K003372 10/30/2000 IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP DIAGNOSTIC PRODUCTS CORP.


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