IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A— 510(k) K884040
Substantially EquivalentOrion Diagnostica, Inc.
FDA 510(k) clearance K884040 for IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A, Substantially Equivalent on 1988-10-19. Applicant: Orion Diagnostica, Inc.. Device class: 2.
Clearance details
- Applicant
- Orion Diagnostica, Inc.
- Product code
- Code CZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 02101 Espoo, FI
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More clearances from Orion Diagnostica, Inc.
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