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FDA 510(k)

RANDOX CREATININE

K-Number: K973993 · 1998-03-06

ApplicantRandox Laboratories, Ltd.
Decision Date1998-03-06
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX CREATININE 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 1998-03-06 under 510(k) number K973993. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX CREATININE?

RANDOX CREATININE is a medical device that received FDA 510(k) clearance on 1998-03-06. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K973993.

When did RANDOX CREATININE receive FDA 510(k) clearance?

RANDOX CREATININE received FDA 510(k) clearance on 1998-03-06, under 510(k) number K973993.

Who is the listed applicant for RANDOX CREATININE?

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 CREATININE?

The FDA product code for RANDOX CREATININE is CGX.

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Other records listing Randox Laboratories, Ltd. as applicant

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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Related Devices (Code: CGX)

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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