IGG SUCLASS EIA— 510(k) K921575
Substantially EquivalentVirotech Diagnostika
FDA 510(k) clearance K921575 for IGG SUCLASS EIA, Substantially Equivalent on 1992-05-28. Applicant: Virotech Diagnostika. Device class: 2.
Clearance details
- Applicant
- Virotech Diagnostika
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Cadwell, NJ, US
Recent devices under product code DEW
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