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FDA 510(k)

S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN

K-Number: K131217 · 2013-06-07

ApplicantHitachi Chemical Diagnostics, Inc.
Decision Date2013-06-07
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-06-07 under 510(k) number K131217. 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 S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN?

S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 2013-06-07. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K131217.

When did S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN receive FDA 510(k) clearance?

S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN received FDA 510(k) clearance on 2013-06-07, under 510(k) number K131217.

Who is the listed applicant for S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN?

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

What is the FDA product code for S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN?

The FDA product code for S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN is CIG.

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Other records listing Hitachi Chemical Diagnostics, 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.

K193613Allergen-Specific IgE Assay 12 Allergen BundleK182793AP3600 Automated InstrumentK132462S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREK130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYK131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST

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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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