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FDA 510(k)

QTMICRO(TM) SYSTEM

K-Number: K950305 · 1995-10-13

ApplicantQ.I. Medical, Inc.
Decision Date1995-10-13
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QTMICRO(TM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Q.I. Medical, Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K950305. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QTMICRO(TM) SYSTEM?

QTMICRO(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Q.I. Medical, Inc.. The 510(k) number is K950305.

When did QTMICRO(TM) SYSTEM receive FDA 510(k) clearance?

QTMICRO(TM) SYSTEM received FDA 510(k) clearance on 1995-10-13, under 510(k) number K950305.

Who is the listed applicant for QTMICRO(TM) SYSTEM?

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

What is the FDA product code for QTMICRO(TM) SYSTEM?

The FDA product code for QTMICRO(TM) SYSTEM is LHI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Q.I. Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K920015QUICKTEST SYSTEM

Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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