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FDA 510(k)

EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690

K-Number: K873424 · 1987-09-14

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-09-14
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 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 1987-09-14 under 510(k) number K873424. 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 CONJUGATED BILIRUBIN (CBIL) #16690?

EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 is a medical device that received FDA 510(k) clearance on 1987-09-14. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K873424.

When did EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 receive FDA 510(k) clearance?

EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 received FDA 510(k) clearance on 1987-09-14, under 510(k) number K873424.

Who is the listed applicant for EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690?

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 CONJUGATED BILIRUBIN (CBIL) #16690?

The FDA product code for EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 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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