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FDA 510(k)

DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.

K-Number: K892905 · 1989-06-19

ApplicantCatachem, Inc.
Decision Date1989-06-19
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1989-06-19 under 510(k) number K892905. 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 DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.?

DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. is a medical device that received FDA 510(k) clearance on 1989-06-19. The listed applicant is Catachem, Inc.. The 510(k) number is K892905.

When did DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. receive FDA 510(k) clearance?

DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. received FDA 510(k) clearance on 1989-06-19, under 510(k) number K892905.

Who is the listed applicant for DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.?

The FDA 510(k) record lists Catachem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.?

The FDA product code for DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. is CIG.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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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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