ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S— 510(k) K811567
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K811567 for ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S, Substantially Equivalent on 1981-09-16. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.