Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls— 510(k) K143502
Substantially EquivalentImmunalysis Corporation
FDA 510(k) clearance K143502 for Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls, Substantially Equivalent on 2015-05-20. Applicant: Immunalysis Corporation.
Clearance details
- Applicant
- Immunalysis Corporation
- Product code
- Code DJG
- 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.