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FDA 510(k)

TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)

K-Number: K030828 · 2003-05-21

ApplicantBeckman Coulter, Inc.
Decision Date2003-05-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K030828. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)?

TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K030828.

When did TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) receive FDA 510(k) clearance?

TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) received FDA 510(k) clearance on 2003-05-21, under 510(k) number K030828.

Who is the listed applicant for TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)?

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

What is the FDA product code for TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)?

The FDA product code for TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) is GKZ.

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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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