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FDA 510(k)

COULTER LIN-X LINEARITY CONTROL

K-Number: K081641 · 2009-01-16

ApplicantBeckman Coulter, Inc.
Decision Date2009-01-16
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER LIN-X LINEARITY 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 2009-01-16 under 510(k) number K081641. 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 LIN-X LINEARITY CONTROL?

COULTER LIN-X LINEARITY CONTROL is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K081641.

When did COULTER LIN-X LINEARITY CONTROL receive FDA 510(k) clearance?

COULTER LIN-X LINEARITY CONTROL received FDA 510(k) clearance on 2009-01-16, under 510(k) number K081641.

Who is the listed applicant for COULTER LIN-X LINEARITY 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 LIN-X LINEARITY CONTROL?

The FDA product code for COULTER LIN-X LINEARITY 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.

K160590XN CHECKStreckK160588XN CHECK BFStreckK160586XN-L CHECKStreckK160606BC-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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