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FDA 510(k)

RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3

K-Number: K113720 · 2012-09-20

ApplicantRandox Laboratories, Ltd.
Decision Date2012-09-20
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX MATERNAL CONTROL, LEVELS 1, 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 2012-09-20 under 510(k) number K113720. 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 MATERNAL CONTROL, LEVELS 1, 2 AND 3?

RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K113720.

When did RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 receive FDA 510(k) clearance?

RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 received FDA 510(k) clearance on 2012-09-20, under 510(k) number K113720.

Who is the listed applicant for RANDOX MATERNAL CONTROL, LEVELS 1, 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 MATERNAL CONTROL, LEVELS 1, 2 AND 3?

The FDA product code for RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 is JJY.

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Other records listing Randox Laboratories, Ltd. as applicant

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Related Devices (Code: JJY)

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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