VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS— 510(k) K062077
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K062077 for VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS, Substantially Equivalent on 2006-11-22. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code DKZ
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- K210858 — VITROS Chemistry Products PHBR Slides
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
Recalls naming K062077
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 K062077.
Data sourced from openFDA. This site is unofficial and independent of the FDA.