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FDA 510(k)

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

K-Number: K111938 · 2012-02-14

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date2012-02-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... 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 2012-02-14 under 510(k) number K111938. 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 IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...?

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... is a medical device that received FDA 510(k) clearance on 2012-02-14. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K111938.

When did IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... receive FDA 510(k) clearance?

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... received FDA 510(k) clearance on 2012-02-14, under 510(k) number K111938.

Who is the listed applicant for IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...?

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 IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...?

The FDA product code for IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... is JJX.

Related Clinical Trials

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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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