510(k) K193358
- Device
- MicroScan Dried Gram-Negative MIC/Combo Panels With Levofloxacin (Lvx) (0.008-16ug/mL)
- Applicant
- Beckman Coulter, Inc.
- 510(k) number
- K193358
- Product code
- LTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-03
- Date received
- 2019-12-04
- 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
- Elaine Duncan
- Address
- 1584 Enterprise Blvd. West Sacramento CA US 95630 95630
FDA Registration Numbers#
- 1119779
- 3031977134
- 1530126
- 3009171251
- 3013661582
- 1924669
- 3003750284
- 3009637528
- 3012389632
- 1950204
- 8021914
- 3013718871
- 2919016
Source Documents#
Legacy Summary#
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FDA Review#
Decision Summary