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FDA 510(k)

CREATININE - A.A.S.

K-Number: K841377 · 1984-05-11

ApplicantAdvanced Analytical Systems, Inc.
Decision Date1984-05-11
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE - A.A.S. is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Analytical Systems, Inc.. It received FDA 510(k) clearance on 1984-05-11 under 510(k) number K841377. 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 - A.A.S.?

CREATININE - A.A.S. is a medical device that received FDA 510(k) clearance on 1984-05-11. The listed applicant is Advanced Analytical Systems, Inc.. The 510(k) number is K841377.

When did CREATININE - A.A.S. receive FDA 510(k) clearance?

CREATININE - A.A.S. received FDA 510(k) clearance on 1984-05-11, under 510(k) number K841377.

Who is the listed applicant for CREATININE - A.A.S.?

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

What is the FDA product code for CREATININE - A.A.S.?

The FDA product code for CREATININE - A.A.S. is CGX.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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