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FDA 510(k)

COULTER LIN-X LINEARITY CONTROL, MODEL A81196

K-Number: K100790 · 2010-12-21

ApplicantBeckman Coulter, Inc.
Decision Date2010-12-21
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER LIN-X LINEARITY CONTROL, MODEL A81196 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 2010-12-21 under 510(k) number K100790. 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, MODEL A81196?

COULTER LIN-X LINEARITY CONTROL, MODEL A81196 is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K100790.

When did COULTER LIN-X LINEARITY CONTROL, MODEL A81196 receive FDA 510(k) clearance?

COULTER LIN-X LINEARITY CONTROL, MODEL A81196 received FDA 510(k) clearance on 2010-12-21, under 510(k) number K100790.

Who is the listed applicant for COULTER LIN-X LINEARITY CONTROL, MODEL A81196?

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, MODEL A81196?

The FDA product code for COULTER LIN-X LINEARITY CONTROL, MODEL A81196 is JPK.

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Other records listing Beckman Coulter, Inc. as applicant

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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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