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FDA 510(k)

ETI-MAX 3000

K-Number: K052794 · 2006-03-31

ApplicantDiaSorin, Inc.
Decision Date2006-03-31
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ETI-MAX 3000 is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2006-03-31 under 510(k) number K052794. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETI-MAX 3000?

ETI-MAX 3000 is a medical device that received FDA 510(k) clearance on 2006-03-31. The listed applicant is DiaSorin, Inc.. The 510(k) number is K052794.

When did ETI-MAX 3000 receive FDA 510(k) clearance?

ETI-MAX 3000 received FDA 510(k) clearance on 2006-03-31, under 510(k) number K052794.

Who is the listed applicant for ETI-MAX 3000?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETI-MAX 3000?

The FDA product code for ETI-MAX 3000 is JJF.

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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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