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FDA 510(k)

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

K-Number: K213510 · 2023-09-08

ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Decision Date2023-09-08
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K213510. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA?

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K213510.

When did IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA receive FDA 510(k) clearance?

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA received FDA 510(k) clearance on 2023-09-08, under 510(k) number K213510.

Who is the listed applicant for IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA?

The FDA product code for IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA is LTK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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