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FDA 510(k)

EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95

K-Number: K872512 · 1987-08-21

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

Device Summary

EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 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 K872512. 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 EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95?

EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 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 K872512.

When did EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 receive FDA 510(k) clearance?

EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 received FDA 510(k) clearance on 1987-08-21, under 510(k) number K872512.

Who is the listed applicant for EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95?

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 EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95?

The FDA product code for EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 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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