510(k) K212461
- Device
- VITEK MS PRIME
- Applicant
- BioMerieux, Inc.
- 510(k) number
- K212461
- Product code
- QBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-15
- Date received
- 2021-08-06
- Regulation
- 866.3378
- Classification name
- 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
- 1119779
- 9615037
- 3009288740
- 3010141591
- 9615754
- 1950204
- 3002444944
Source Documents#
Other 510(k) Records For Product Code QBN #
Legacy Summary#
summary
FDA Review#
Decision Summary