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FDA 510(k)

RANDOX C-REACTIVE PROTEIN

K-Number: K001009 · 2000-08-04

ApplicantRandox Laboratories, Ltd.
Decision Date2000-08-04
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RANDOX C-REACTIVE PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2000-08-04 under 510(k) number K001009. 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 RANDOX C-REACTIVE PROTEIN?

RANDOX C-REACTIVE PROTEIN is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K001009.

When did RANDOX C-REACTIVE PROTEIN receive FDA 510(k) clearance?

RANDOX C-REACTIVE PROTEIN received FDA 510(k) clearance on 2000-08-04, under 510(k) number K001009.

Who is the listed applicant for RANDOX C-REACTIVE PROTEIN?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RANDOX C-REACTIVE PROTEIN?

The FDA product code for RANDOX C-REACTIVE PROTEIN is 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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