ADVIA Centaur CA 125II
K-Number: K200199 · 2020-04-06
ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2020-04-06
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
ADVIA Centaur CA 125II is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-04-06 under approval number K200199. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADVIA Centaur CA 125II?
ADVIA Centaur CA 125II is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200199.
When was ADVIA Centaur CA 125II approved by the FDA?
ADVIA Centaur CA 125II received FDA 510(k) clearance on 2020-04-06, under approval number K200199.
What company makes ADVIA Centaur CA 125II?
ADVIA Centaur CA 125II is manufactured by Siemens Healthcare Diagnostics, Inc..
What is the FDA product code for ADVIA Centaur CA 125II?
The FDA product code for ADVIA Centaur CA 125II is LTK.
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: LTK)
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.