SS-A(RO) & SS-B(LA) ANTIBODY ASSAY— 510(k) K852033
Substantially EquivalentMeloy Laboratories, Inc.
FDA 510(k) clearance K852033 for SS-A(RO) & SS-B(LA) ANTIBODY ASSAY, Substantially Equivalent on 1985-06-21. Applicant: Meloy Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Meloy Laboratories, 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
- Springfield, VA, US
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