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FDA 510(k)

COULTER BODY FLUID CONTROL

K-Number: K082162 · 2009-02-03

ApplicantBeckman Coulter, Inc.
Decision Date2009-02-03
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER BODY FLUID CONTROL 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 2009-02-03 under 510(k) number K082162. 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 BODY FLUID CONTROL?

COULTER BODY FLUID CONTROL is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K082162.

When did COULTER BODY FLUID CONTROL receive FDA 510(k) clearance?

COULTER BODY FLUID CONTROL received FDA 510(k) clearance on 2009-02-03, under 510(k) number K082162.

Who is the listed applicant for COULTER BODY FLUID CONTROL?

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 BODY FLUID CONTROL?

The FDA product code for COULTER BODY FLUID CONTROL is JPK.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: JPK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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