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FDA 510(k)

COULTER 6C CELL CONTROL, MODELS 628027 & A59925

K-Number: K081822 · 2009-01-21

ApplicantBeckman Coulter, Inc.
Decision Date2009-01-21
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER 6C CELL CONTROL, MODELS 628027 & A59925 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 2009-01-21 under 510(k) number K081822. 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 COULTER 6C CELL CONTROL, MODELS 628027 & A59925?

COULTER 6C CELL CONTROL, MODELS 628027 & A59925 is a medical device that received FDA 510(k) clearance on 2009-01-21. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K081822.

When did COULTER 6C CELL CONTROL, MODELS 628027 & A59925 receive FDA 510(k) clearance?

COULTER 6C CELL CONTROL, MODELS 628027 & A59925 received FDA 510(k) clearance on 2009-01-21, under 510(k) number K081822.

Who is the listed applicant for COULTER 6C CELL CONTROL, MODELS 628027 & A59925?

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 6C CELL CONTROL, MODELS 628027 & A59925?

The FDA product code for COULTER 6C CELL CONTROL, MODELS 628027 & A59925 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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