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FDA 510(k)

EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604

K-Number: K872513 · 1987-08-21

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-08-21
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 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 1987-08-21 under 510(k) number K872513. 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 EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604?

EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 is a medical device that received FDA 510(k) clearance on 1987-08-21. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K872513.

When did EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 receive FDA 510(k) clearance?

EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 received FDA 510(k) clearance on 1987-08-21, under 510(k) number K872513.

Who is the listed applicant for EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604?

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 EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604?

The FDA product code for EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 is CIG.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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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