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FDA 510(k)

DIR. QUANT. COLOR. DETERM. SERUM CREAT.

K-Number: K771856 · 1977-11-03

ApplicantStanbio Laboratory
Decision Date1977-11-03
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIR. QUANT. COLOR. DETERM. SERUM CREAT. is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K771856. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIR. QUANT. COLOR. DETERM. SERUM CREAT.?

DIR. QUANT. COLOR. DETERM. SERUM CREAT. is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is Stanbio Laboratory. The 510(k) number is K771856.

When did DIR. QUANT. COLOR. DETERM. SERUM CREAT. receive FDA 510(k) clearance?

DIR. QUANT. COLOR. DETERM. SERUM CREAT. received FDA 510(k) clearance on 1977-11-03, under 510(k) number K771856.

Who is the listed applicant for DIR. QUANT. COLOR. DETERM. SERUM CREAT.?

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 DIR. QUANT. COLOR. DETERM. SERUM CREAT.?

The FDA product code for DIR. QUANT. COLOR. DETERM. SERUM CREAT. is CGX.

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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: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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