EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT— 510(k) K901080
Substantially EquivalentImmunotech Corp.
FDA 510(k) clearance K901080 for EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1990-05-17. Applicant: Immunotech Corp.. Device class: 2.
Clearance details
- Applicant
- Immunotech Corp.
- Product code
- Code DIP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
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