IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES— 510(k) K970198
Substantially EquivalentScimedx Corp.
FDA 510(k) clearance K970198 for IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES, Substantially Equivalent on 1997-02-20. Applicant: Scimedx Corp.. Device class: 2.
Clearance details
- Applicant
- Scimedx Corp.
- 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
- Denvill, NJ, US
Recent devices under product code DHN
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