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FDA 510(k)

QUAN. COLOR. DETER. OF SERUM ALBUMIN

K-Number: K771771 · 1977-10-07

ApplicantStanbio Laboratory
Decision Date1977-10-07
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUAN. COLOR. DETER. OF SERUM ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1977-10-07 under 510(k) number K771771. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUAN. COLOR. DETER. OF SERUM ALBUMIN?

QUAN. COLOR. DETER. OF SERUM ALBUMIN is a medical device that received FDA 510(k) clearance on 1977-10-07. The listed applicant is Stanbio Laboratory. The 510(k) number is K771771.

When did QUAN. COLOR. DETER. OF SERUM ALBUMIN receive FDA 510(k) clearance?

QUAN. COLOR. DETER. OF SERUM ALBUMIN received FDA 510(k) clearance on 1977-10-07, under 510(k) number K771771.

Who is the listed applicant for QUAN. COLOR. DETER. OF SERUM ALBUMIN?

The FDA 510(k) record lists Stanbio Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUAN. COLOR. DETER. OF SERUM ALBUMIN?

The FDA product code for QUAN. COLOR. DETER. OF SERUM ALBUMIN is DCF.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.

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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