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FDA 510(k)

DIRECT BILIRUBIN

K-Number: K860257 · 1986-02-21

ApplicantPointe Scientific, Inc.,
Decision Date1986-02-21
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1986-02-21 under 510(k) number K860257. 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 DIRECT BILIRUBIN?

DIRECT BILIRUBIN is a medical device that received FDA 510(k) clearance on 1986-02-21. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K860257.

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

DIRECT BILIRUBIN received FDA 510(k) clearance on 1986-02-21, under 510(k) number K860257.

Who is the listed applicant for DIRECT BILIRUBIN?

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

What is the FDA product code for DIRECT BILIRUBIN?

The FDA product code for DIRECT BILIRUBIN is CIG.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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