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FDA 510(k)

ADVIA CHEMISTRY TOTAL BILIRUBIN_2

K-Number: K063845 · 2007-12-07

ApplicantBayer Healthcare, LLC
Decision Date2007-12-07
Product CodeJFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY TOTAL BILIRUBIN_2 is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K063845. 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?

ADVIA CHEMISTRY TOTAL BILIRUBIN_2 is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K063845.

When did ADVIA CHEMISTRY TOTAL BILIRUBIN_2 receive FDA 510(k) clearance?

ADVIA CHEMISTRY TOTAL BILIRUBIN_2 received FDA 510(k) clearance on 2007-12-07, under 510(k) number K063845.

Who is the listed applicant for ADVIA CHEMISTRY TOTAL BILIRUBIN_2?

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

What is the FDA product code for ADVIA CHEMISTRY TOTAL BILIRUBIN_2?

The FDA product code for ADVIA CHEMISTRY TOTAL BILIRUBIN_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.

K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.K152343Direct BilirubinRandox Laboratories LimitedK152344Total BilirubinRandox Laboratories LimitedK053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc.K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc.K053090DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATORBeckman Coulter, Inc.

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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