ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K— 510(k) K822682
Substantially EquivalentAmico Lab, Inc.
FDA 510(k) clearance K822682 for ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K, Substantially Equivalent on 1982-12-03. Applicant: Amico Lab, Inc.. Device class: 2.
Clearance details
- Applicant
- Amico Lab, Inc.
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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