ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST— 510(k) K895339
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K895339 for ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST, Substantially Equivalent on 1989-10-04. Applicant: Immco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
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