510(k) K162950
- Device
- VITEK MS
- Applicant
- BioMerieux, Inc.
- 510(k) number
- K162950
- Product code
- PEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-22
- Date received
- 2016-10-24
- Regulation
- 866.3361
- Classification name
- System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nathan Hardesty
- Address
- 595 Anglum Rd. Hazelwood MO US 63042 63042
FDA Registration Numbers#
- 3010191749
- 3003961381
- 3018426298
- 3010099434
- 9615754
Source Documents#
Other 510(k) Records For Product Code PEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | Bruker Daltonik GmbH | 2017-07-26 |
| K142677 | MALDI Biotyper CA System | Bruker Daltonics, Inc. | 2015-03-27 |
| K130831 | MALDI BIOTYPER CA (MBT-CA) SYSTEM | Bruker Daltonics, Inc. | 2013-11-21 |
| DEN130013 | VITEK MS | bioMerieux, Inc. | 2013-08-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary