SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay— 510(k) K203647
Substantially EquivalentImmunalysis Corporation
FDA 510(k) clearance K203647 for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay, Substantially Equivalent on 2021-12-22. Applicant: Immunalysis Corporation.
Clearance details
- Applicant
- Immunalysis Corporation
- Product code
- Code LAF
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pomona, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.