HOMOCYSTEINE TEST
FDA 510(k) clearance K113793 · decided 2012-06-05
Clearance details
- K-number
- K113793
- Device name
- HOMOCYSTEINE TEST
- Applicant
- Roche
- Decision
- Substantially Equivalent
- Date received
- 2011-12-23
- Decision date
- 2012-06-05
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- LPS
- Device class
- 2
- Regulation number
- 862.1377
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on coba recall (Z-0489-2025) | Roche Diagnostics Operations, Inc. | 2024-11-19 |
| Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, coba recall (Z-1622-2015) | Roche Diagnostics Operations, Inc. | 2015-05-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas® EGFR Mutation Test, v2.0 (P120019/S042) | Roche | 2025-12-31 |
| cobas EGFR Mutation Test v2 (P120019/S027) | Roche | 2025-01-27 |
| COBAS EGFR MUTATION TEST (P120019/S040) | Roche | 2024-10-10 |
| Roche cobas EFGR Mutation Test, v2.0 (P120019/S038) | Roche | 2023-12-21 |
| cobas® EGFR Mutation Test, v2.0 (P120019/S037) | Roche | 2023-12-14 |
| cobas® EGFR Mutation Test (P120019/S036) | Roche | 2023-08-23 |
| Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD (P120019/S035) | Roche | 2023-08-17 |
| cobas® EGFR Mutation Test (P120019/S033) | Roche | 2022-11-29 |