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FDA 510(k)

TOTAL BILIRUBIN REAGENT

K-Number: K830714 · 1983-04-06

ApplicantHi Chem, Inc.
Decision Date1983-04-06
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830714. 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 TOTAL BILIRUBIN REAGENT?

TOTAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Hi Chem, Inc.. The 510(k) number is K830714.

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

TOTAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830714.

Who is the listed applicant for TOTAL BILIRUBIN REAGENT?

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

What is the FDA product code for TOTAL BILIRUBIN REAGENT?

The FDA product code for TOTAL BILIRUBIN REAGENT is CIG.

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K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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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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