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FDA 510(k)

ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)

K-Number: K170065 · 2017-03-09

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2017-03-09
Product CodeJFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) 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 2017-03-09 under 510(k) number K170065. The device is classified under product code JFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)?

ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K170065.

When did ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) receive FDA 510(k) clearance?

ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) received FDA 510(k) clearance on 2017-03-09, under 510(k) number K170065.

Who is the listed applicant for ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)?

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 ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)?

The FDA product code for ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) is JFM.

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Related Devices (Code: JFM)

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.

K152343Direct BilirubinRandox Laboratories LimitedK152344Total BilirubinRandox Laboratories Limited

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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