VITROS Immunodiagnostic Products CK-MB Reagent Pack— 510(k) K212648

Name: FDA 510(k) clearance K212648
Creator: U.S. Food and Drug Administration
Published: 2022-01-28

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K212648 for VITROS Immunodiagnostic Products CK-MB Reagent Pack, Substantially Equivalent on 2022-01-28. Applicant: Ortho Clinical Diagnostics. Device class: 2.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code JHX
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2021-08-23
Decision date: 2022-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pencoed, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHX

view all

K234005 — Access CK-MB2024-02-16
K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX2017-09-21
K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE2012-11-21
K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II2009-08-17
K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.2005-09-08

More clearances from Ortho Clinical Diagnostics

view all

K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack2024-08-28
K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack2024-05-08
K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack2023-09-05
K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack2023-08-23
K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack2023-08-09

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