Atellica CH Amylase_2 (AMY_2)
K-Number: K191454 · 2019-07-30
ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-07-30
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Atellica CH Amylase_2 (AMY_2) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-07-30 under approval number K191454. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atellica CH Amylase_2 (AMY_2)?
Atellica CH Amylase_2 (AMY_2) is a medical device that received FDA 510(k) clearance on 2019-07-30. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K191454.
When was Atellica CH Amylase_2 (AMY_2) approved by the FDA?
Atellica CH Amylase_2 (AMY_2) received FDA 510(k) clearance on 2019-07-30, under approval number K191454.
What company makes Atellica CH Amylase_2 (AMY_2)?
Atellica CH Amylase_2 (AMY_2) is manufactured by Siemens Healthcare Diagnostics, Inc..
What is the FDA product code for Atellica CH Amylase_2 (AMY_2)?
The FDA product code for Atellica CH Amylase_2 (AMY_2) is JFJ.
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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.