VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS— 510(k) K062165
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K062165 for VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS, Substantially Equivalent on 2007-01-05. Applicant: Ortho-Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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More clearances from Ortho-Clinical Diagnostics
view all- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
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Recalls naming K062165
K-number listed on FDA's recall record- Z-0911-2018 — VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
- Z-0912-2018 — VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
- Z-0913-2018 — VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
- Z-0914-2018 — VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
- Z-0915-2018 — VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062165.
Data sourced from openFDA. This site is unofficial and independent of the FDA.