510(k) K162385
- Device
- RAPIDEC CARBA NP
- Applicant
- BIOMERIEUX SA
- 510(k) number
- K162385
- Product code
- PTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-27
- Date received
- 2016-08-25
- Regulation
- 866.1640
- Classification name
- Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, 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
- ASA KARLSSON
- Address
- 5 Rue Des Aqueducs Craponne FR 69290 69290
FDA Registration Numbers#
- 9615754
- 3012516784
- 3009963993
Source Documents#
Other 510(k) Records For Product Code PTJ #
Legacy Summary#
summary
FDA Review#
Decision Summary