VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS— 510(k) K984321
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K984321 for VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS, Substantially Equivalent on 1999-01-22. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code CDD
view all- K233541 — ARCHITECT Active-B12 (Holotranscobalamin)
- K223289 — Access Vitamin B12
- K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
- K192064 — LIAISON Vitamin B12
- K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
More clearances from Ortho-Clinical Diagnostics, Inc.
view all- K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
- DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- K210858 — VITROS Chemistry Products PHBR Slides
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
Recalls naming K984321
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984321.
Data sourced from openFDA. This site is unofficial and independent of the FDA.