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FDA 510(k)

RANDOX LIQUID CRP CONTROLS

K-Number: K040351 · 2004-03-12

ApplicantRandox Laboratories, Ltd.
Decision Date2004-03-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX LIQUID CRP CONTROLS 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 2004-03-12 under 510(k) number K040351. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX LIQUID CRP CONTROLS?

RANDOX LIQUID CRP CONTROLS is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K040351.

When did RANDOX LIQUID CRP CONTROLS receive FDA 510(k) clearance?

RANDOX LIQUID CRP CONTROLS received FDA 510(k) clearance on 2004-03-12, under 510(k) number K040351.

Who is the listed applicant for RANDOX LIQUID CRP CONTROLS?

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 LIQUID CRP CONTROLS?

The FDA product code for RANDOX LIQUID CRP CONTROLS is JJX.

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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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