SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389— 510(k) K024162
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K024162 for SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389, Substantially Equivalent on 2003-02-19. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CFF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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