FDA 510(k)

C-REACTIVE PROTEIN LATEX KIT

K-Number: K954447 · 1995-12-18

Decision Date1995-12-18

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

C-REACTIVE PROTEIN LATEX KIT 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 1995-12-18 under 510(k) number K954447. 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 C-REACTIVE PROTEIN LATEX KIT?

C-REACTIVE PROTEIN LATEX KIT is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K954447.

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

C-REACTIVE PROTEIN LATEX KIT received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954447.

Who is the listed applicant for C-REACTIVE PROTEIN LATEX KIT?

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 C-REACTIVE PROTEIN LATEX KIT?

The FDA product code for C-REACTIVE PROTEIN LATEX KIT is DCK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.