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. Device class: 2.
Clearance details
- Applicant
- Immunalysis Corporation
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pomona, CA, US
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More clearances from Immunalysis Corporation
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