QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT— 510(k) K841864
Substantially EquivalentKallestad Laboratories, Inc.
FDA 510(k) clearance K841864 for QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT, Substantially Equivalent on 1984-07-11. Applicant: Kallestad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code DEH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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