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FDA 510(k)

Atellica® CH Creatinine_3 (Crea3)

K-Number: K242685 · 2024-12-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2024-12-04
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica® CH Creatinine_3 (Crea3) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-12-04 under approval number K242685. 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 Atellica® CH Creatinine_3 (Crea3)?

Atellica® CH Creatinine_3 (Crea3) is a medical device that received FDA 510(k) clearance on 2024-12-04. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K242685.

When was Atellica® CH Creatinine_3 (Crea3) approved by the FDA?

Atellica® CH Creatinine_3 (Crea3) received FDA 510(k) clearance on 2024-12-04, under approval number K242685.

What company makes Atellica® CH Creatinine_3 (Crea3)?

Atellica® CH Creatinine_3 (Crea3) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® CH Creatinine_3 (Crea3)?

The FDA product code for Atellica® CH Creatinine_3 (Crea3) is CGX.

Other Devices by Siemens Healthcare Diagnostics, Inc.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161964ADVIA Centaur HAV IgM Assay K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

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Related Devices (Code: CGX)

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc. K210452Creatinine2Abbott Ireland Diagnostics Division K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation

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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