510(k) K203748
- Device
- SeptiCyte RAPID
- Applicant
- Immunexpress, Inc.
- 510(k) number
- K203748
- Product code
- PRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-29
- Date received
- 2020-12-23
- Regulation
- 866.3215
- Classification name
- Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LaKesha Hunt-Dickens
- Address
- 425 Pontius Ave. N., Suite 470 Seattle WA US 98109 98109
FDA Registration Numbers#
- 3009972873
- 3016504919
- 3022977716