510(k) K000121
- Device
- IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K000121
- Product code
- DFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-17
- Date received
- 2000-01-18
- Regulation
- 866.5600
- Classification name
- Lipoprotein, Low-density, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNETTE HELLIE
- Address
- 200 S. Kraemer Blvd.,M/S W-104 Box 8000 Brea CA US 92822 92822
FDA Registration Numbers#
- 2030861
- 3016438761
- 1000403749
- 3005333358
- 3006198300
- 3004493545
- 9680746
- 2085064
- 3002809144
- 3005094123
- 2029372
- 9610126
- 3003795116
- 9610806
- 1181121
- 2084025
- 8032314
- 2032900
- 1318354
- 1827821
- 2050012
- 9610529
- 9610746
- 9681753
- 2050010
- 3014607865
- 2432235
Source Documents#
Other 510(k) Records For Product Code DFC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | 2025-01-24 |
| K211058 | Lp(a) Ultra | SENTINEL CH. SpA | 2022-12-22 |
| K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | 2018-03-22 |
| K123046 | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-12-20 |
| K122722 | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 | Roche Diagnostics | 2012-11-29 |
| K082488 | DIAZYME LP(A) ASSAY | General Atomics | 2009-01-13 |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | Thermo Electron OY | 2007-09-27 |
| K050487 | QUANTIA LA(A) | Biokit, S.A. | 2005-04-26 |
| K023853 | K-ASSAY LP(A) CONTROLS | Kamiya Biomedical Co. | 2002-12-13 |
| K021660 | K-ASSAY LP(A) ASSAY | Kamiya Biomedical Co. | 2002-07-25 |
| K013359 | LP(A)-LATEX SEIKEN ASSAY KIT | Denka Seiken'S | 2002-03-08 |
| K013128 | N LATEX LP(A) | Dade Behring, Inc. | 2002-01-18 |
| K013206 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | 2001-11-16 |
| K013207 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | 2001-11-13 |
| K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | 2000-07-24 |
Legacy Summary#
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FDA Review#
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