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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2017-05-10 under 510(k) 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. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K171080.

When did ALP IFCC Gen.2 receive FDA 510(k) clearance?

ALP IFCC Gen.2 received FDA 510(k) clearance on 2017-05-10, under 510(k) number K171080.

Who is the listed applicant for ALP IFCC Gen.2?

The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALP IFCC Gen.2?

The FDA product code for ALP IFCC Gen.2 is CJE.

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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.

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