ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT— 510(k) K802461
Substantially EquivalentImmunotech Corp.
FDA 510(k) clearance K802461 for ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1980-10-31. Applicant: Immunotech Corp.. Device class: 2.
Clearance details
- Applicant
- Immunotech Corp.
- Product code
- Code LCW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3300
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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