Company ยท US
Diagnostic Products Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2006. Name variants (Inc, Corp, punctuation) are merged.
324510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 26 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 11 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 10 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 8 |
| CDD | Radioassay, Vitamin B12 | 7 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 6 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 6 |
| DGC | Ige, Antigen, Antiserum, Control | 6 |
| DJG | Enzyme Immunoassay, Opiates | 6 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 6 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 5 |
| CGR | Radioimmunoassay, Cortisol | 5 |
| CHP | Radioimmunoassay, Estradiol | 5 |
| DKZ | Enzyme Immunoassay, Amphetamine | 5 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 5 |
| CDX | Radioimmunoassay, Total Thyroxine | 4 |
| CGN | Acid, Folic, Radioimmunoassay | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2006 | K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP Diagnostic Products Corporation | NQD |
| Dec 5, 2006 | K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN Diagnostic Products Corp. | LEH |
| Apr 28, 2006 | K060929 | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 Diagnostic Products Corporation | CDD |
| Feb 3, 2006 | K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH Diagnostic Products Corporation | CEW |
| Jan 21, 2004 | K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I Diagnostic Products Corp. | JHX |
| Dec 12, 2003 | K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp. | DHA |
| Oct 10, 2003 | K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE Diagnostic Products Corp. | CDZ |
| Dec 17, 2002 | K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE Diagnostic Products Corp. | DHB |
| Dec 9, 2002 | K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL Diagnostic Products Corp. | JKR |
| Aug 21, 2002 | K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp. | CEW |
| Jul 22, 2002 | K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) Diagnostic Products Corp. | JHX |
| Jun 3, 2002 | K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) Diagnostic Products Corp. | LKJ |
| May 30, 2002 | K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS Diagnostic Products Corp. | DHB |
| May 30, 2002 | K021206 | IMMULITE 2000 SPECIFIC ALLERGENS Diagnostic Products Corp. | DHB |
| Mar 28, 2002 | K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR Diagnostic Products Corp. | MOI |
| Jan 10, 2002 | K012077 | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 Diagnostic Products Corp. | LFX |
| Jan 10, 2002 | K012075 | IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 Diagnostic Products Corp. | LGD |
| Nov 20, 2001 | K013566 | IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 Diagnostic Products Corp. | CEW |
| Oct 19, 2001 | K013135 | IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) Diagnostic Products Corp. | DHB |
| Oct 15, 2001 | K013134 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) Diagnostic Products Corp. | DHB |
| Sep 19, 2001 | K012301 | IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) Diagnostic Products Corp. | KXT |
| Aug 20, 2001 | K012312 | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) Diagnostic Products Corp. | KLB |
| Aug 20, 2001 | K012311 | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) Diagnostic Products Corp. | LCD |
| Jul 2, 2001 | K011505 | IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 Diagnostic Products Corp. | CEW |
| Apr 18, 2001 | K010878 | MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 Diagnostic Products Corp. | LGC |
| Feb 14, 2001 | K004002 | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) Diagnostic Products Corp. | JHX |
| Feb 5, 2001 | K003597 | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 Diagnostic Products Corp. | LPS |
| Dec 26, 2000 | K003372 | IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP Diagnostic Products Corp. | DCN |
| Jun 1, 2000 | K000463 | IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG Diagnostic Products Corp. | LYR |
| Mar 3, 2000 | K000012 | IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 Diagnostic Products Corp. | DLZ |
| Mar 3, 2000 | K000005 | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 Diagnostic Products Corp. | LEG |
| Feb 28, 2000 | K000007 | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 Diagnostic Products Corp. | KLT |
| Feb 28, 2000 | K000006 | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 Diagnostic Products Corp. | DIP |
| Feb 23, 2000 | K000257 | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 Diagnostic Products Corp. | JFH |
| Jan 28, 2000 | K994085 | IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 Diagnostic Products Corp. | DHA |
| Jan 27, 2000 | K992632 | IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 Diagnostic Products Corp. | DKZ |
| Jan 20, 2000 | K992634 | IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 Diagnostic Products Corp. | LAF |
| Dec 16, 1999 | K993952 | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 Diagnostic Products Corp. | LFZ |
| Nov 17, 1999 | K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 Diagnostic Products Corp. | LIG |
| Nov 12, 1999 | K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 Diagnostic Products Corp. | CGN |
| Jul 12, 1999 | K983203 | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 Diagnostic Products Corp. | GGT |
| Jul 6, 1999 | K992105 | IMMULITE TURBO INTACT PTH, MODEL LSKPTZ Diagnostic Products Corp. | CEW |
| Jun 9, 1999 | K991797 | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 Diagnostic Products Corp. | JHX |
| Jun 9, 1999 | K991796 | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 Diagnostic Products Corp. | DDR |
| Jun 9, 1999 | K991795 | IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 Diagnostic Products Corp. | MMI |
| May 13, 1999 | K991096 | IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 Diagnostic Products Corp. | JZO |
| May 13, 1999 | K991094 | IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 Diagnostic Products Corp. | JZO |
| Apr 27, 1999 | K991277 | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 Diagnostic Products Corp. | DDR |
| Apr 6, 1999 | K990886 | IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 Diagnostic Products Corp. | DCK |
| Mar 18, 1999 | K983336 | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 Diagnostic Products Corp. | LKT |
Newest 50 of 324.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2006 | Diagnostic Products Corp. IMMULITE 2000 Total Testosterone Kit Terminated |
CDZ | K032881 |
| Jul 16, 2005 | Diagnostic Products Corp Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 Terminated |
DHX | K970877 |
| Feb 11, 2005 | Diagnostic Products Corp IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186. Terminated |
CDD | K993251 |
| Dec 17, 2004 | Diagnostic Products Corp Immulite 2500 insulin Kit Terminated |
CFP | None listed |
| Jul 20, 2004 | Diagnostic Products Corp Immulite 1000 CEA
Catalog No. LKCE1 Terminated |
DHX | K970877 |
| Jul 20, 2004 | Diagnostic Products Corp IMMULITE 2000 Intact PTH kit Terminated |
CEW | K013566 |
| Sep 11, 2003 | Diagnostic Products Corp Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit) Terminated |
LYR | K000463 |