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FDA 510(k)

COBAS STANDARDS FOR CREATININE

K-Number: K823572 · 1983-01-07

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-01-07
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS STANDARDS FOR CREATININE is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823572. 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 COBAS STANDARDS FOR CREATININE?

COBAS STANDARDS FOR CREATININE is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K823572.

When did COBAS STANDARDS FOR CREATININE receive FDA 510(k) clearance?

COBAS STANDARDS FOR CREATININE received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823572.

Who is the listed applicant for COBAS STANDARDS FOR CREATININE?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS STANDARDS FOR CREATININE?

The FDA product code for COBAS STANDARDS FOR CREATININE is CGX.

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Other records listing Hoffmann-La Roche, 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.

K850727BHCG-ROCHE EIAK831694RENAKK830462ABUSCREEN RADIOUMMUNOASSAY--URINEK830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAK830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

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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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