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FDA 510(k)

SYSMEX MODEL UF1000I

K-Number: K070910 · 2007-05-25

ApplicantSysmex America, Inc.
Decision Date2007-05-25
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX MODEL UF1000I is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K070910. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX MODEL UF1000I?

SYSMEX MODEL UF1000I is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Sysmex America, Inc.. The 510(k) number is K070910.

When did SYSMEX MODEL UF1000I receive FDA 510(k) clearance?

SYSMEX MODEL UF1000I received FDA 510(k) clearance on 2007-05-25, under 510(k) number K070910.

Who is the listed applicant for SYSMEX MODEL UF1000I?

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

What is the FDA product code for SYSMEX MODEL UF1000I?

The FDA product code for SYSMEX MODEL UF1000I is LKM.

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Other records listing Sysmex America, Inc. as applicant

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Related Devices (Code: LKM)

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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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