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FDA 510(k)

ALBUMIN REAGENT SET

K-Number: K905776 · 1991-02-26

ApplicantBiochemical Trade, Inc.
Decision Date1991-02-26
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K905776. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN REAGENT SET?

ALBUMIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K905776.

When did ALBUMIN REAGENT SET receive FDA 510(k) clearance?

ALBUMIN REAGENT SET received FDA 510(k) clearance on 1991-02-26, under 510(k) number K905776.

Who is the listed applicant for ALBUMIN REAGENT SET?

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

What is the FDA product code for ALBUMIN REAGENT SET?

The FDA product code for ALBUMIN REAGENT SET is CJW.

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Other records listing Biochemical Trade, 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.

K942958CREATINE KINASE MB DETERMINATION (UV)K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905790TOTAL PROTEIN REAGENT SETK905650KINETIC ALKALINE PHOSPHATASE DETERMINATIONK905619CREATININE (RATE) REAGENT SET

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Related Devices (Code: CJW)

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.

K203530Albumin BCP2Abbott Ireland Diagnostics DivisionK193001Albumin BCPSENTINEL CH. SpAK132664ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATORSiemens Healthcare Diagnostics, Inc.K021636ALBUMIN REAGENTIntersect Systems, Inc.K000483RANDOX ALBUMINRandox Laboratories, Ltd.K990978ALBUMIN BCG, MODEL AL 103-01A.P. Total Care, Inc.

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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