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FDA 510(k)

DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.

K-Number: K880397 · 1988-03-15

ApplicantData Medical Associates, Inc.
Decision Date1988-03-15
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880397. 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 PROCEDURE RUN ON A AU5000 INSTRU.?

DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K880397.

When did DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. receive FDA 510(k) clearance?

DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880397.

Who is the listed applicant for DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.?

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

What is the FDA product code for DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.?

The FDA product code for DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. is CIG.

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Other records listing Data Medical Associates, Inc. as applicant

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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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