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FDA 510(k)

N-ASSAY L D-BIL

K-Number: K981276 · 1998-05-01

ApplicantCrestat Diagnostics, Inc.
Decision Date1998-05-01
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-ASSAY L D-BIL is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K981276. 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 N-ASSAY L D-BIL?

N-ASSAY L D-BIL is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K981276.

When did N-ASSAY L D-BIL receive FDA 510(k) clearance?

N-ASSAY L D-BIL received FDA 510(k) clearance on 1998-05-01, under 510(k) number K981276.

Who is the listed applicant for N-ASSAY L D-BIL?

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

What is the FDA product code for N-ASSAY L D-BIL?

The FDA product code for N-ASSAY L D-BIL is CIG.

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Other records listing Crestat Diagnostics, 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.

K980883N-ASSAY GLU-ULK981289N-ASSAY L T-BILK980902N-ASSAY L AST/GOTK980900N-ASSAY CPK-LK971985N-ASSAY TIA PLASMINOGEN TEST KITK972257N-ASSAY TIA ANTITHROMBIN III TEST KIT

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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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