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FDA 510(k)

COULTER A T 5DIFF CAP PIERCE (CP)

K-Number: K042173 · 2004-10-12

ApplicantBeckman Coulter, Inc.
Decision Date2004-10-12
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER A T 5DIFF CAP PIERCE (CP) 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 2004-10-12 under 510(k) number K042173. 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 COULTER A T 5DIFF CAP PIERCE (CP)?

COULTER A T 5DIFF CAP PIERCE (CP) is a medical device that received FDA 510(k) clearance on 2004-10-12. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K042173.

When did COULTER A T 5DIFF CAP PIERCE (CP) receive FDA 510(k) clearance?

COULTER A T 5DIFF CAP PIERCE (CP) received FDA 510(k) clearance on 2004-10-12, under 510(k) number K042173.

Who is the listed applicant for COULTER A T 5DIFF CAP PIERCE (CP)?

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 COULTER A T 5DIFF CAP PIERCE (CP)?

The FDA product code for COULTER A T 5DIFF CAP PIERCE (CP) 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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