VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III— 510(k) K982649
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K982649 for VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III, Substantially Equivalent on 1998-08-12. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.