B.R.A.H.M.S PCT sensitive KRYPTOR
FDA 510(k) clearance DEN150009 · decided 2016-02-20
Clearance details
- K-number
- DEN150009
- Device name
- B.R.A.H.M.S PCT sensitive KRYPTOR
- Applicant
- Brahms GmbH
- Decision
- Unknown
- Date received
- 2015-03-04
- Decision date
- 2016-02-20
- Days to decision
- 353 days
- Clearance type
- Direct
- Product code
- PMT
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Henningsdorf, DE
- 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 |
| Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729) | Roche Diagnostics | 2016-06-13 |
Recalls involving this device
No recalls on record reference this clearance.