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FDA 510(k)

CREATININE

K-Number: K850932 · 1985-06-25

ApplicantDilab, Inc.
Decision Date1985-06-25
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE is the device name listed in this FDA 510(k) record. The listed applicant is Dilab, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K850932. 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 CREATININE?

CREATININE is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Dilab, Inc.. The 510(k) number is K850932.

When did CREATININE receive FDA 510(k) clearance?

CREATININE received FDA 510(k) clearance on 1985-06-25, under 510(k) number K850932.

Who is the listed applicant for CREATININE?

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

What is the FDA product code for CREATININE?

The FDA product code for CREATININE is CGX.

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Other records listing Dilab, 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.

K862530RAPID AS LATEXK850931ALBUMINK850934PHOSPHORUSK850933URIC ACIDK850936TOTAL PROTEINSK850938CHOLESTEROL

View all 11 devices →

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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