Atellica IM Ferritin Assay
K-Number: K171642 · 2017-08-31
ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2017-08-31
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Atellica IM Ferritin Assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval number K171642. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atellica IM Ferritin Assay?
Atellica IM Ferritin Assay is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K171642.
When was Atellica IM Ferritin Assay approved by the FDA?
Atellica IM Ferritin Assay received FDA 510(k) clearance on 2017-08-31, under approval number K171642.
What company makes Atellica IM Ferritin Assay?
Atellica IM Ferritin Assay is manufactured by Siemens Healthcare Diagnostics, Inc..
What is the FDA product code for Atellica IM Ferritin Assay?
The FDA product code for Atellica IM Ferritin Assay is DBF.
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)
Related Devices (Code: DBF)
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.