SERATEST RF LATEX DETERMINATION— 510(k) K840863
Substantially EquivalentSeragen Diagnostics, Inc.
FDA 510(k) clearance K840863 for SERATEST RF LATEX DETERMINATION, Substantially Equivalent on 1984-04-04. Applicant: Seragen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Seragen Diagnostics, Inc.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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