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FDA 510(k)

Atellica IM Total hCG (ThCG)

K-Number: K172322 · 2018-03-29

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-03-29
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica IM Total hCG (ThCG) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-03-29 under 510(k) number K172322. The device is classified under product code JHI. 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 2018-03-29. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K172322.

When did Atellica IM Total hCG (ThCG) receive FDA 510(k) clearance?

Atellica IM Total hCG (ThCG) received FDA 510(k) clearance on 2018-03-29, under 510(k) number K172322.

Who is the listed applicant for Atellica IM Total hCG (ThCG)?

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

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

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

Other records listing Siemens Healthcare Diagnostics, Inc. as applicant

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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