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FDA 510(k)

4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190

K-Number: K010064 · 2001-02-07

ApplicantBeckman Coulter, Inc.
Decision Date2001-02-07
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 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 2001-02-07 under 510(k) number K010064. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190?

4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 is a medical device that received FDA 510(k) clearance on 2001-02-07. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K010064.

When did 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 receive FDA 510(k) clearance?

4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 received FDA 510(k) clearance on 2001-02-07, under 510(k) number K010064.

Who is the listed applicant for 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190?

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 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190?

The FDA product code for 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 is JPK.

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Other records listing Beckman Coulter, Inc. as applicant

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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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