Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators— 510(k) K161714
Substantially EquivalentImmunalysis Corporation
FDA 510(k) clearance K161714 for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators, Substantially Equivalent on 2016-10-14. Applicant: Immunalysis Corporation. Device class: 2.
Clearance details
- Applicant
- Immunalysis Corporation
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- 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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