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FDA 510(k)

CK-NAC ACTIVATED KIT

K-Number: K923511 · 1992-10-15

ApplicantRandox Laboratories, Ltd.
Decision Date1992-10-15
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-NAC ACTIVATED 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 1992-10-15 under 510(k) number K923511. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-NAC ACTIVATED KIT?

CK-NAC ACTIVATED KIT is a medical device that received FDA 510(k) clearance on 1992-10-15. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K923511.

When did CK-NAC ACTIVATED KIT receive FDA 510(k) clearance?

CK-NAC ACTIVATED KIT received FDA 510(k) clearance on 1992-10-15, under 510(k) number K923511.

Who is the listed applicant for CK-NAC ACTIVATED 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 CK-NAC ACTIVATED KIT?

The FDA product code for CK-NAC ACTIVATED KIT is CGS.

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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: CGS)

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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