Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Diagnostic Products Corp. — Predicate Candidate Screening

321 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time
179 days90th percentile
321clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINDiagnostic Products Corp.2006-12-05620
K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IDiagnostic Products Corp.2004-01-21221
K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERDiagnostic Products Corp.2003-12-12673
K032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 Diagnostic Products Corp.2003-10-10252
K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEDiagnostic Products Corp.2002-12-17850
K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2Diagnostic Products Corp.2002-12-09671
K022603IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZERDiagnostic Products Corp.2002-08-21152
K022118IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500Diagnostic Products Corp.2002-07-22211
K021257ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)Diagnostic Products Corp.2002-06-03450
K021206IMMULITE 2000 SPECIFIC ALLERGENSDiagnostic Products Corp.2002-05-30441
K021208IMMULITE 2000 MIXED ALLERGEN PANELSDiagnostic Products Corp.2002-05-30441
K013984IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KDiagnostic Products Corp.2002-03-281152
K012075IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 200Diagnostic Products Corp.2002-01-101920
K012077IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGMDiagnostic Products Corp.2002-01-101920
K013566IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 Diagnostic Products Corp.2001-11-20252
K013135IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANEDiagnostic Products Corp.2001-10-19300
K013134IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, Diagnostic Products Corp.2001-10-15262
K012301IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 Diagnostic Products Corp.2001-09-19610
K012311IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 Diagnostic Products Corp.2001-08-20280
K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 Diagnostic Products Corp.2001-08-20280
K011505IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESDiagnostic Products Corp.2001-07-02470
K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & LDiagnostic Products Corp.2001-04-18300
K004002IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); Diagnostic Products Corp.2001-02-14502
K003597IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEIDiagnostic Products Corp.2001-02-05760
K003372IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITDiagnostic Products Corp.2000-12-26570
K000463IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGGDiagnostic Products Corp.2000-06-011111
K000012IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Diagnostic Products Corp.2000-03-03600
K000005IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOGDiagnostic Products Corp.2000-03-03600
K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1Diagnostic Products Corp.2000-02-28560
K000007IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOGDiagnostic Products Corp.2000-02-28560
K000257IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6Diagnostic Products Corp.2000-02-23270
K994085IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5Diagnostic Products Corp.2000-01-28560
K992632IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5Diagnostic Products Corp.2000-01-271740
K992634IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5Diagnostic Products Corp.2000-01-201670
K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6Diagnostic Products Corp.1999-12-16240
K993251IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6Diagnostic Products Corp.1999-11-17501
K993254IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06Diagnostic Products Corp.1999-11-12451
K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.1999-07-123010
K992105IMMULITE TURBO INTACT PTH, MODEL LSKPTZDiagnostic Products Corp.1999-07-06140
K991796IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5Diagnostic Products Corp.1999-06-09140
K991795IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5Diagnostic Products Corp.1999-06-09141
K991797IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5Diagnostic Products Corp.1999-06-09140
K991094IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6Diagnostic Products Corp.1999-05-13422
K991096IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06Diagnostic Products Corp.1999-05-13420
K991277MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5Diagnostic Products Corp.1999-04-27130
K990886IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5Diagnostic Products Corp.1999-04-06200
K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.1999-03-181760
K982466IMMULITE THYROGLOBULIN MODEL LKTYDiagnostic Products Corp.1999-03-122401
K982468IMMULITE 2000 THYROGLOBULIN MODEL L2KTYDiagnostic Products Corp.1999-03-122403
K990222IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL LDiagnostic Products Corp.1999-02-26320

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda