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FDA 510(k)

HBA1C CONTROL, LEVEL 1 AND LEVEL 2

K-Number: K131999 · 2013-07-26

ApplicantRandox Laboratories, Ltd.
Decision Date2013-07-26
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HBA1C CONTROL, LEVEL 1 AND LEVEL 2 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 2013-07-26 under 510(k) number K131999. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBA1C CONTROL, LEVEL 1 AND LEVEL 2?

HBA1C CONTROL, LEVEL 1 AND LEVEL 2 is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K131999.

When did HBA1C CONTROL, LEVEL 1 AND LEVEL 2 receive FDA 510(k) clearance?

HBA1C CONTROL, LEVEL 1 AND LEVEL 2 received FDA 510(k) clearance on 2013-07-26, under 510(k) number K131999.

Who is the listed applicant for HBA1C CONTROL, LEVEL 1 AND LEVEL 2?

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 HBA1C CONTROL, LEVEL 1 AND LEVEL 2?

The FDA product code for HBA1C CONTROL, LEVEL 1 AND LEVEL 2 is JJX.

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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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