510(k) K131275
- Device
- MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
- Applicant
- SIEMENS HELATHCARE DIAGNOSTICS INC.
- 510(k) number
- K131275
- Product code
- LTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-08
- Date received
- 2013-05-03
- Regulation
- 866.1640
- Classification name
- Panels, Test, Susceptibility, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELISABETH WARINER
- Address
- 1584 Enterprise Blvd. West Sacramento CA US 95691 95691
FDA Registration Numbers#
- 3013718871
- 1950204
- 3003750284
- 1119779
- 3013661582
- 1924669
- 3009637528
- 3012389632
- 3031977134
- 2919016
- 1530126
- 8021914
- 3009171251
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary