ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
FDA 510(k) clearance K123046 · decided 2012-12-20
Clearance details
- K-number
- K123046
- Device name
- ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-28
- Decision date
- 2012-12-20
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lipoprotein (a) Molarity Assay (K253069) | Diazyme Laboratories, Inc. | 2026-06-16 |
| Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220) | Roche Diagnostics Operations | 2025-01-24 |
| Lp(a) Ultra (K211058) | SENTINEL CH. SpA | 2022-12-22 |
| Diazyme Lipoprotein (a) Assay (K180074) | Diazyme Laboratories, Inc. | 2018-03-22 |
| COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 (K122722) | Roche Diagnostics | 2012-11-29 |
| DIAZYME LP(A) ASSAY (K082488) | General Atomics | 2009-01-13 |
| LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (K063838) | Thermo Electron OY | 2007-09-27 |
| QUANTIA LA(A) (K050487) | Biokit, S.A. | 2005-04-26 |
| K-ASSAY LP(A) CONTROLS (K023853) | Kamiya Biomedical Co. | 2002-12-13 |
| K-ASSAY LP(A) ASSAY (K021660) | Kamiya Biomedical Co. | 2002-07-25 |
| LP(A)-LATEX SEIKEN ASSAY KIT (K013359) | Denka Seiken'S | 2002-03-08 |
| N LATEX LP(A) (K013128) | Dade Behring, Inc. | 2002-01-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 PSA (P930027/S039) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| IMMULITE 2000 AFP (P010007/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| Atellica IM free PSA II (fPSAII) (P250026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| IMMULITE 2000 AFP (P010007/S025) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| IMMULITE 2000 PSA (P930027/S038) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |