510(k) K160729
- Device
- Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
- Applicant
- Roche Diagnostics
- 510(k) number
- K160729
- Product code
- PMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-13
- Date received
- 2016-03-16
- Regulation
- 866.3215
- Classification name
- Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adam Clark
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 2432235
- 3012963943
- 2032682
- 1319681
- 3007111389
- 3002642396
- 2250051
- 3002809144
- 9610240
- 3003561301
- 3005847079
- 1181121
- 2029372
- 3002895169
- 9610126
- 8020790
- 3008344661
- 3005360469
- 3000308930
- 1219913
- 3005333358
Source Documents#
Other 510(k) Records For Product Code PMT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | Ortho Clinical Diagnostics | 2020-02-25 |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 |
| K160911 | VIDAS B.R.A.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016-06-28 |
| DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTOR | Brahms GmbH | 2016-02-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary