ORTHO* UNASSAYED CONTROL SERUM LEVEL I— 510(k) K813321
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K813321 for ORTHO* UNASSAYED CONTROL SERUM LEVEL I, Substantially Equivalent on 1981-12-17. Applicant: Ortho Diagnostic Systems, Inc..
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code JJY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
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