FDA 510(k)

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3

K-Number: K121603 · 2012-11-20

Decision Date2012-11-20

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 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 2012-11-20 under 510(k) number K121603. 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 IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3?

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K121603.

When did RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 receive FDA 510(k) clearance?

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 received FDA 510(k) clearance on 2012-11-20, under 510(k) number K121603.

Who is the listed applicant for RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 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 IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3?

The FDA product code for RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 is JJY.

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Related Devices (Code: JJY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.