Diagnostic Products Corp. - FDA 510(k) Cleared Devices
Recent clearances: IMMULITE 2000, IMMULITE 2500 VANCOMYCIN, IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I, IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
321
Total
321
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diagnostic Products Corp. Chemistry ✕
150 devices
Cleared
Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
Chemistry
22d
Cleared
Dec 12, 2003
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
Chemistry
67d
Cleared
Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
Chemistry
25d
Cleared
Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN,...
Chemistry
67d
Cleared
Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
Chemistry
21d
Cleared
Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS),...
Chemistry
25d
Cleared
Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
Chemistry
28d
Cleared
Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE...
Chemistry
47d
Cleared
Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
Chemistry
50d
Cleared
Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
Chemistry
56d
Cleared
Nov 17, 1999
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
Chemistry
50d
Cleared
Nov 12, 1999
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
Chemistry
45d
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