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FDA 510(k)

TOTAL & DIRECT BILIRUBIN PROCEDURES

K-Number: K832942 · 1983-11-07

ApplicantSandare Chemical Co., Inc.
Decision Date1983-11-07
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL & DIRECT BILIRUBIN PROCEDURES is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K832942. 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 & DIRECT BILIRUBIN PROCEDURES?

TOTAL & DIRECT BILIRUBIN PROCEDURES is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K832942.

When did TOTAL & DIRECT BILIRUBIN PROCEDURES receive FDA 510(k) clearance?

TOTAL & DIRECT BILIRUBIN PROCEDURES received FDA 510(k) clearance on 1983-11-07, under 510(k) number K832942.

Who is the listed applicant for TOTAL & DIRECT BILIRUBIN PROCEDURES?

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

What is the FDA product code for TOTAL & DIRECT BILIRUBIN PROCEDURES?

The FDA product code for TOTAL & DIRECT BILIRUBIN PROCEDURES is CIG.

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Other records listing Sandare Chemical Co., 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.

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTK862556SANDARE GLYCOHEMOGLOBIN PROCEDUREK860684SANDARE BCG ALBUMIN PROCEDUREK851395SANDARE IRON-BINDING CAPACITY PROCEDUREK851394SANDARE IRON PROCEDUREK844498SANDARE ALKALINE PHOSPHATASE PROCEDURE

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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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