Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

321 results for "Diagnostic Products Corp."
1–24 of 321
Search insights Median review: 50d Cleared: 100% Top manufacturer: Diagnostic Products Corp. Lead specialty: Chemistry
Cleared Dec 05, 2006
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · LEH
Diagnostic Products Corp.
Toxicology · 62d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · JHX
Diagnostic Products Corp.
Chemistry · 22d
Cleared Dec 12, 2003
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
K033234 · DHA
Diagnostic Products Corp.
Chemistry · 67d
Cleared Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · CDZ
Diagnostic Products Corp.
Chemistry · 25d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN,...
K023304 · JKR
Diagnostic Products Corp.
Chemistry · 67d
Cleared Aug 21, 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · CEW
Diagnostic Products Corp.
Toxicology · 15d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · JHX
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ
Diagnostic Products Corp.
Immunology · 45d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
K013984 · MOI
Diagnostic Products Corp.
Immunology · 115d
Cleared Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2,...
K012077 · LFX
Diagnostic Products Corp.
Microbiology · 192d
Cleared Jan 10, 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM,...
K012075 · LGD
Diagnostic Products Corp.
Microbiology · 192d
Cleared Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS),...
K013566 · CEW
Diagnostic Products Corp.
Chemistry · 25d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6...
K013135 · DHB
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600...
K013134 · DHB
Diagnostic Products Corp.
Immunology · 26d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · KXT
Diagnostic Products Corp.
Toxicology · 61d
Cleared Aug 20, 2001
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · KLB
Diagnostic Products Corp.
Toxicology · 28d
Cleared Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · LCD
Diagnostic Products Corp.
Chemistry · 28d
Cleared Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE...
K011505 · CEW
Diagnostic Products Corp.
Chemistry · 47d
Cleared Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · LGC
Diagnostic Products Corp.
Microbiology · 30d
Cleared Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
K004002 · JHX
Diagnostic Products Corp.
Chemistry · 50d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · LPS
Diagnostic Products Corp.
Toxicology · 76d