510(k) K171338
- Device
- B R A H M S PCT Sensitive KRYPTOR
- Applicant
- B.R.A.H.M.S GmbH
- 510(k) number
- K171338
- Product code
- PRI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-31
- Date received
- 2017-05-08
- Regulation
- 866.3215
- Classification name
- Procalcitonin Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sascha Johannes
- Address
- Neuendorfstr. 25 Henningsdorf DE 16761 16761
FDA Registration Numbers#
- 3002895169
- 9610126
- 3002809144
- 8020790
- 9610240
- 3003561301
- 3005847079
- 2032839
- 1181121
- 3008344661
- 3005333358
- 2517506
Source Documents#
Other 510(k) Records For Product Code PRI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 |
| K192815 | Elecsys BRAHMS PCT | Roche Diagnostics | 2020-03-09 |
| K173927 | Elecsys BRAHMS PCT | Roche Diagnostics | 2018-07-06 |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers | DiaSorin, Inc. | 2018-02-27 |
| K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set | Fujirebio Diagnostics,Inc. | 2017-12-10 |
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls | Fisher Diagnostics | 2017-06-01 |
| K162827 | VIDAS B.R.A.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017-02-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary