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FDA 510(k)

RX IMOLA

K-Number: K052914 · 2006-03-31

ApplicantRandox Laboratories, Ltd.
Decision Date2006-03-31
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RX IMOLA 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 2006-03-31 under 510(k) number K052914. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX IMOLA?

RX IMOLA is a medical device that received FDA 510(k) clearance on 2006-03-31. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K052914.

When did RX IMOLA receive FDA 510(k) clearance?

RX IMOLA received FDA 510(k) clearance on 2006-03-31, under 510(k) number K052914.

Who is the listed applicant for RX IMOLA?

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 RX IMOLA?

The FDA product code for RX IMOLA is CEM.

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Other records listing Randox Laboratories, Ltd. as applicant

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Related Devices (Code: CEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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