KALLESTAD HEP-2 CELL LINE SUBSTRATE— 510(k) K810863
Substantially EquivalentKallestad Laboratories, Inc.
FDA 510(k) clearance K810863 for KALLESTAD HEP-2 CELL LINE SUBSTRATE, Substantially Equivalent on 1981-04-14. Applicant: Kallestad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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