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FDA 510(k)

TOTAL & DIRECT BILIRUBIN REAGENT SET

K-Number: K812841 · 1981-11-27

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-11-27
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL & DIRECT BILIRUBIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-11-27 under 510(k) number K812841. 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 REAGENT SET?

TOTAL & DIRECT BILIRUBIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-11-27. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K812841.

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

TOTAL & DIRECT BILIRUBIN REAGENT SET received FDA 510(k) clearance on 1981-11-27, under 510(k) number K812841.

Who is the listed applicant for TOTAL & DIRECT BILIRUBIN REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KIT

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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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