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FDA 510(k)

QC-BEADS

K-Number: K042750 · 2004-10-29

ApplicantBioscreen, Inc.
Decision Date2004-10-29
Product CodeNRF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QC-BEADS is the device name listed in this FDA 510(k) record. The listed applicant is Bioscreen, Inc.. It received FDA 510(k) clearance on 2004-10-29 under 510(k) number K042750. 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 QC-BEADS?

QC-BEADS is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Bioscreen, Inc.. The 510(k) number is K042750.

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

QC-BEADS received FDA 510(k) clearance on 2004-10-29, under 510(k) number K042750.

Who is the listed applicant for QC-BEADS?

The FDA 510(k) record lists Bioscreen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QC-BEADS?

The FDA product code for QC-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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