VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS— 510(k) K990016

Name: FDA 510(k) clearance K990016
Creator: U.S. Food and Drug Administration
Published: 1999-05-19

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K990016 for VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS, Substantially Equivalent on 1999-05-19. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1999-01-04
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJY

view all

K162530 — Multichem IA Plus2017-03-31
K163629 — Audit MicroControls Linearity FD Tumor Markers II2017-03-10
K163015 — Liquichek Tumor Marker Control-Level 1 +3 more2017-01-10
K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit2016-01-28
K150300 — Liquichek Cardiac Markers Plus Control LT2015-12-11

More clearances from Ortho-Clinical Diagnostics, Inc.

view all

K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack2025-10-29
DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator2023-05-05
DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators2023-05-05
K210858 — VITROS Chemistry Products PHBR Slides2021-08-13
K191316 — VITROS XT Chemistry Products ALB-TP Slides2019-06-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.