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FDA 510(k)

OLYMPUS(TM) TOTAL BILIRUBIN

K-Number: K897174 · 1990-05-10

ApplicantEm Diagnostic Systems, Inc.
Decision Date1990-05-10
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS(TM) TOTAL BILIRUBIN 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 1990-05-10 under 510(k) number K897174. 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 OLYMPUS(TM) TOTAL BILIRUBIN?

OLYMPUS(TM) TOTAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 1990-05-10. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K897174.

When did OLYMPUS(TM) TOTAL BILIRUBIN receive FDA 510(k) clearance?

OLYMPUS(TM) TOTAL BILIRUBIN received FDA 510(k) clearance on 1990-05-10, under 510(k) number K897174.

Who is the listed applicant for OLYMPUS(TM) TOTAL BILIRUBIN?

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 OLYMPUS(TM) TOTAL BILIRUBIN?

The FDA product code for OLYMPUS(TM) TOTAL BILIRUBIN is CIG.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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