Diagnostic Products Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
321
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINDecember 5, 2006
K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IJanuary 21, 2004
K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERDecember 12, 2003
K032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEOctober 10, 2003
K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEDecember 17, 2002
K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCLDecember 9, 2002
K022603IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZERAugust 21, 2002
K022118IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)July 22, 2002
K021257ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)June 3, 2002
K021206IMMULITE 2000 SPECIFIC ALLERGENSMay 30, 2002
K021208IMMULITE 2000 MIXED ALLERGEN PANELSMay 30, 2002
K013984IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBRMarch 28, 2002
K012077IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6January 10, 2002
K012075IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTMJanuary 10, 2002
K013566IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (November 20, 2001
K013135IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)October 19, 2001
K013134IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)October 15, 2001
K012301IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)September 19, 2001
K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)August 20, 2001
K012311IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)August 20, 2001