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FDA 510(k)

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

K-Number: K040579 · 2004-06-18

ApplicantCholestech Corp.
Decision Date2004-06-18
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 2004-06-18 under 510(k) number K040579. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)?

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) is a medical device that received FDA 510(k) clearance on 2004-06-18. The listed applicant is Cholestech Corp.. The 510(k) number is K040579.

When did CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) receive FDA 510(k) clearance?

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) received FDA 510(k) clearance on 2004-06-18, under 510(k) number K040579.

Who is the listed applicant for CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)?

The FDA 510(k) record lists Cholestech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)?

The FDA product code for CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) is DCK.

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Related Devices (Code: DCK)

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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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