IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA— 510(k) K213510

Name: FDA 510(k) clearance K213510
Creator: U.S. Food and Drug Administration
Published: 2023-09-08

Substantially Equivalent

Siemens Healthcare Diagnostics Products, Ltd.

FDA 510(k) clearance K213510 for IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA, Substantially Equivalent on 2023-09-08. Applicant: Siemens Healthcare Diagnostics Products, Ltd.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Products, Ltd.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2021-11-02
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanberis, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LTK

view all

K240479 — Access OV Monitor2024-05-10
K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack2022-12-12
K200199 — ADVIA Centaur CA 125II2020-04-06
K143534 — Elecsys CA-125 II assay2015-08-06
K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators2015-05-21

More clearances from Siemens Healthcare Diagnostics Products, Ltd.

view all

K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)2026-09-04
K233946 — IMMULITE® 2000 BR-MA2024-03-13
K202826 — IMMULITE® 2000 Cortisol2021-01-15
K203270 — IMMULITE/IMMULITE® 1000 Cortisol2021-01-15

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