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FDA 510(k)

IDS-ISYS IFG-I CONTROL SET

K-Number: K110412 · 2011-03-16

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date2011-03-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDS-ISYS IFG-I CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K110412. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS-ISYS IFG-I CONTROL SET?

IDS-ISYS IFG-I CONTROL SET is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K110412.

When did IDS-ISYS IFG-I CONTROL SET receive FDA 510(k) clearance?

IDS-ISYS IFG-I CONTROL SET received FDA 510(k) clearance on 2011-03-16, under 510(k) number K110412.

Who is the listed applicant for IDS-ISYS IFG-I CONTROL SET?

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

What is the FDA product code for IDS-ISYS IFG-I CONTROL SET?

The FDA product code for IDS-ISYS IFG-I CONTROL SET is JJX.

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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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