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FDA 510(k)

SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406

K-Number: K895119 · 1989-10-17

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-10-17
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895119. 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 SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406?

SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K895119.

When did SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 receive FDA 510(k) clearance?

SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895119.

Who is the listed applicant for SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406?

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

What is the FDA product code for SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406?

The FDA product code for SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 is CIG.

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Other records listing Em Diagnostic Systems, 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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