510(k) K012593
- Device
- VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- 510(k) number
- K012593
- Product code
- LBR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-30
- Date received
- 2001-08-10
- Regulation
- 862.1475
- Classification name
- Ldl & Vldl Precipitation, Hdl
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARLENE A SHULMAN
- Address
- 100 Indigo Creek Dr. Rochester NY US 14626 14626
FDA Registration Numbers#
- 3008959428
- 8020316
- 3021010433
- 9615507
- 3004146366
- 3005333358
- 3002736372
- 3003539867
- 3013660430
- 1319808
- 3000308930
- 2085064
- 1649661
- 1616487
- 3011061417
- 3023162659
- 3002642396
- 3000148879
- 3003593973
- 9610126
- 1219029
- 3012133212
- 1319809
- 3010891909
- 3003419906
- 2032900
- 3012963943
- 1832216
- 3015525148
- 3004111573
- 3021841051
- 1827821
- 2250051
- 9613069
- 3003522182
- 3020885868
- 2030633
- 2531491
- 1319681
Source Documents#
Other 510(k) Records For Product Code LBR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | 2015-01-28 |
| K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | General Atomics | 2008-01-22 |
| K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | Teco Diagnostics | 2005-07-26 |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | Hemagen Diagnostics, Inc. | 2002-12-24 |
| K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Diagnostics | 1999-08-12 |
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET | Pointe Scientific, Inc., | 1999-08-05 |
| K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Holdings, Inc. | 1999-07-09 |
| K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | 1999-05-28 |
| K984303 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT | Ortho-Clinical Diagnostics, Inc. | 1999-01-28 |
| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | Diagnostic Chemicals , Ltd. | 1998-04-27 |
| K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | Diagnostic Chemicals , Ltd. | 1998-04-21 |
| K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | Boehringer Mannheim Corp. | 1998-01-26 |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | 1997-06-18 |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Trace America, Inc. | 1997-03-13 |
Legacy Summary#
summary
FDA Review#
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