FANA 60— 510(k) K854314
Substantially EquivalentAmerican Bio-Reagents, Inc.
FDA 510(k) clearance K854314 for FANA 60, Substantially Equivalent on 1985-12-16. Applicant: American Bio-Reagents, Inc.. Device class: 2.
Clearance details
- Applicant
- American Bio-Reagents, 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
- Easton, PA, US
Recent devices under product code DHN
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