Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
FDA 510(k) clearance K160729 · decided 2016-06-13
Clearance details
- K-number
- K160729
- Device name
- Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2016-03-16
- Decision date
- 2016-06-13
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- PMT
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| VITROS BRAHMS PCT Reagent Pack and Calibrators (K200236) | Ortho Clinical Diagnostics | 2020-02-25 |
| Atellica IM BRAHMS Procalcitonin (PCT) (K181002) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K160911) | bioMerieux, Inc. | 2016-06-28 |
| B.R.A.H.M.S PCT sensitive KRYPTOR (DEN150009) | Brahms GmbH | 2016-02-20 |
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 |