ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX— 510(k) K821975
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K821975 for ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX, Substantially Equivalent on 1982-08-27. Applicant: Ortho Diagnostic Systems, Inc..
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code DIF
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.