Cleared Traditional

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA

K213510 · Siemens Healthcare Diagnostics Products, Ltd. · Immunology
Sep 2023
Decision
675d
Days
Class 2
Risk

About This 510(k) Submission

K213510 is an FDA 510(k) clearance for the IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Siemens Healthcare Diagnostics Products, Ltd. (Llanberis, GB). The FDA issued a Cleared decision on September 8, 2023, 675 days after receiving the submission on November 2, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K213510 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2021
Decision Date September 08, 2023
Days to Decision 675 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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