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FDA 510(k)

NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95

K-Number: K855079 · 1986-03-05

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-03-05
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 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 1986-03-05 under 510(k) number K855079. 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 NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95?

NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K855079.

When did NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 receive FDA 510(k) clearance?

NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 received FDA 510(k) clearance on 1986-03-05, under 510(k) number K855079.

Who is the listed applicant for NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95?

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 NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95?

The FDA product code for NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 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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