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FDA 510(k)

Atellica IM Total hCG (ThCG)

K-Number: K192790 · 2019-10-30

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-10-30
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica IM Total hCG (ThCG) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-10-30 under approval number K192790. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica IM Total hCG (ThCG)?

Atellica IM Total hCG (ThCG) is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K192790.

When was Atellica IM Total hCG (ThCG) approved by the FDA?

Atellica IM Total hCG (ThCG) received FDA 510(k) clearance on 2019-10-30, under approval number K192790.

What company makes Atellica IM Total hCG (ThCG)?

Atellica IM Total hCG (ThCG) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica IM Total hCG (ThCG)?

The FDA product code for Atellica IM Total hCG (ThCG) is DHA.

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Related Devices (Code: DHA)

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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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