VITROS BRAHMS PCT Reagent Pack and Calibrators
FDA 510(k) clearance K200236 · decided 2020-02-25
Clearance details
- K-number
- K200236
- Device name
- VITROS BRAHMS PCT Reagent Pack and Calibrators
- Applicant
- Ortho Clinical Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2020-01-30
- Decision date
- 2020-02-25
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- PMT
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho Clinical Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729) | Roche Diagnostics | 2016-06-13 |
| 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 |
|---|---|---|
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017) | Ortho-Clinical Diagnostics | 2023-01-24 |
| VITROS Anti-HBe (P100001/S016) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Anti-HBc (P030024/S029) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027) | Ortho-Clinical Diagnostics | 2018-10-16 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026) | Ortho-Clinical Diagnostics | 2018-07-02 |