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FDA 510(k)

QWIKCHECK-BEADS

K-Number: K041600 · 2004-07-27

ApplicantMedical Electronics Systems , Ltd.
Decision Date2004-07-27
Product CodeNRF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QWIKCHECK-BEADS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronics Systems , Ltd.. It received FDA 510(k) clearance on 2004-07-27 under 510(k) number K041600. The device is classified under product code NRF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QWIKCHECK-BEADS?

QWIKCHECK-BEADS is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Medical Electronics Systems , Ltd.. The 510(k) number is K041600.

When did QWIKCHECK-BEADS receive FDA 510(k) clearance?

QWIKCHECK-BEADS received FDA 510(k) clearance on 2004-07-27, under 510(k) number K041600.

Who is the listed applicant for QWIKCHECK-BEADS?

The FDA 510(k) record lists Medical Electronics Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QWIKCHECK-BEADS?

The FDA product code for QWIKCHECK-BEADS is NRF.

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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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