COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
FDA 510(k) clearance K122722 · decided 2012-11-29
Clearance details
- K-number
- K122722
- Device name
- COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2012-09-05
- Decision date
- 2012-11-29
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| Lp(a) Ultra (K211058) | SENTINEL CH. SpA | 2022-12-22 |
| Diazyme Lipoprotein (a) Assay (K180074) | Diazyme Laboratories, Inc. | 2018-03-22 |
| ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (K123046) | Siemens Healthcare Diagnostics, Inc. | 2012-12-20 |
| 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 |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |