BI-LEVEL ASSAYED URINE METAL CONTROL— 510(k) K820255
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K820255 for BI-LEVEL ASSAYED URINE METAL CONTROL, Substantially Equivalent on 1982-02-18. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- 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.