FDA 510(k)

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE

K-Number: K093910 · 2010-07-12

ApplicantGuangzhou Improve Medical Instruments Co., Ltd.

Decision Date2010-07-12

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Improve Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2010-07-12 under 510(k) number K093910. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPROVACUTER GEL & CLOT ACTIVATOR TUBE?

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE is a medical device that received FDA 510(k) clearance on 2010-07-12. The listed applicant is Guangzhou Improve Medical Instruments Co., Ltd.. The 510(k) number is K093910.

When did IMPROVACUTER GEL & CLOT ACTIVATOR TUBE receive FDA 510(k) clearance?

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE received FDA 510(k) clearance on 2010-07-12, under 510(k) number K093910.

Who is the listed applicant for IMPROVACUTER GEL & CLOT ACTIVATOR TUBE?

The FDA 510(k) record lists Guangzhou Improve Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPROVACUTER GEL & CLOT ACTIVATOR TUBE?

The FDA product code for IMPROVACUTER GEL & CLOT ACTIVATOR TUBE is JKA.

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Related Devices (Code: JKA)

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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.