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FDA 510(k)

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

K-Number: K082210 · 2008-12-16

ApplicantGenzyme Diagnostics P.E.I., Inc.
Decision Date2008-12-16
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K082210. 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 TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30?

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Genzyme Diagnostics P.E.I., Inc.. The 510(k) number is K082210.

When did TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 receive FDA 510(k) clearance?

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 received FDA 510(k) clearance on 2008-12-16, under 510(k) number K082210.

Who is the listed applicant for TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30?

The FDA 510(k) record lists Genzyme Diagnostics P.E.I., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30?

The FDA product code for TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 is CIG.

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Other records listing Genzyme Diagnostics P.E.I., 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.

K081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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