ALP IFCC Gen.2
K-Number: K171080 · 2017-05-10
ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2017-05-10
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ALP IFCC Gen.2 is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2017-05-10 under approval number K171080. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ALP IFCC Gen.2?
ALP IFCC Gen.2 is a medical device that received FDA 510(k) clearance on 2017-05-10. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K171080.
When was ALP IFCC Gen.2 approved by the FDA?
ALP IFCC Gen.2 received FDA 510(k) clearance on 2017-05-10, under approval number K171080.
What company makes ALP IFCC Gen.2?
ALP IFCC Gen.2 is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for ALP IFCC Gen.2?
The FDA product code for ALP IFCC Gen.2 is CJE.
Other Devices by Roche Diagnostics Operations (Rdo)
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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.