VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA— 510(k) K001266
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K001266 for VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA, Substantially Equivalent on 2000-05-02. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
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Recalls naming K001266
K-number listed on FDA's recall record- Z-2580-2024 — VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- Z-0058-2019 — VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001266.
Data sourced from openFDA. This site is unofficial and independent of the FDA.