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FDA 510(k)

5C-ES CELL CONTROL, MODELS 7547191, 7547192

K-Number: K010066 · 2001-02-07

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

Device Summary

5C-ES CELL CONTROL, MODELS 7547191, 7547192 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 K010066. 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 5C-ES CELL CONTROL, MODELS 7547191, 7547192?

5C-ES CELL CONTROL, MODELS 7547191, 7547192 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 K010066.

When did 5C-ES CELL CONTROL, MODELS 7547191, 7547192 receive FDA 510(k) clearance?

5C-ES CELL CONTROL, MODELS 7547191, 7547192 received FDA 510(k) clearance on 2001-02-07, under 510(k) number K010066.

Who is the listed applicant for 5C-ES CELL CONTROL, MODELS 7547191, 7547192?

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 5C-ES CELL CONTROL, MODELS 7547191, 7547192?

The FDA product code for 5C-ES CELL CONTROL, MODELS 7547191, 7547192 is JPK.

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Related Devices (Code: JPK)

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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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