Atellica IM Folate Assay
K-Number: K172201 · 2018-04-12
ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-04-12
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Atellica IM Folate Assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-04-12 under approval number K172201. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atellica IM Folate Assay?
Atellica IM Folate Assay is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K172201.
When was Atellica IM Folate Assay approved by the FDA?
Atellica IM Folate Assay received FDA 510(k) clearance on 2018-04-12, under approval number K172201.
What company makes Atellica IM Folate Assay?
Atellica IM Folate Assay is manufactured by Siemens Healthcare Diagnostics, Inc..
What is the FDA product code for Atellica IM Folate Assay?
The FDA product code for Atellica IM Folate Assay is CGN.
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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.