TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER— 510(k) K891683
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K891683 for TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER, Substantially Equivalent on 1989-04-12. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CZN
- 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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