ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT— 510(k) K875066
Substantially EquivalentDexall Biomedical Labs, Inc.
FDA 510(k) clearance K875066 for ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT, Substantially Equivalent on 1988-01-29. Applicant: Dexall Biomedical Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Dexall Biomedical Labs, Inc.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
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