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FDA 510(k)

RANDOX CSF CONTROLS LEVELS 2 AND 3

K-Number: K132156 · 2013-10-23

ApplicantRandox Laboratories, Ltd.
Decision Date2013-10-23
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX CSF CONTROLS LEVELS 2 AND 3 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 2013-10-23 under 510(k) number K132156. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX CSF CONTROLS LEVELS 2 AND 3?

RANDOX CSF CONTROLS LEVELS 2 AND 3 is a medical device that received FDA 510(k) clearance on 2013-10-23. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K132156.

When did RANDOX CSF CONTROLS LEVELS 2 AND 3 receive FDA 510(k) clearance?

RANDOX CSF CONTROLS LEVELS 2 AND 3 received FDA 510(k) clearance on 2013-10-23, under 510(k) number K132156.

Who is the listed applicant for RANDOX CSF CONTROLS LEVELS 2 AND 3?

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 CSF CONTROLS LEVELS 2 AND 3?

The FDA product code for RANDOX CSF CONTROLS LEVELS 2 AND 3 is JJY.

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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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