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FDA 510(k)

CARESIDE DIRECT BILIRUBIN

K-Number: K993771 · 1999-12-27

ApplicantCareside, Inc.
Decision Date1999-12-27
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE DIRECT BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 1999-12-27 under 510(k) number K993771. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE DIRECT BILIRUBIN?

CARESIDE DIRECT BILIRUBIN is a medical device that received FDA 510(k) clearance on 1999-12-27. The listed applicant is Careside, Inc.. The 510(k) number is K993771.

When did CARESIDE DIRECT BILIRUBIN receive FDA 510(k) clearance?

CARESIDE DIRECT BILIRUBIN received FDA 510(k) clearance on 1999-12-27, under 510(k) number K993771.

Who is the listed applicant for CARESIDE DIRECT BILIRUBIN?

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

What is the FDA product code for CARESIDE DIRECT BILIRUBIN?

The FDA product code for CARESIDE DIRECT BILIRUBIN is CIG.

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Other records listing Careside, Inc. as applicant

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.

K020484CARESIDE LDHK020486CARESIDE GGTK020487CARESIDE ALTK020488CARESIDE TRGLYCERIDEK002792CARESIDE CHOLINESTERASEK001462CARESIDE HEMOGLOBIN

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Related Devices (Code: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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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