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FDA 510(k)

NOVACYTE-U

K-Number: K862665 · 1986-09-04

ApplicantXsirius Medical, Inc.
Decision Date1986-09-04
Product CodeKDT
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

NOVACYTE-U is the device name listed in this FDA 510(k) record. The listed applicant is Xsirius Medical, Inc.. It received FDA 510(k) clearance on 1986-09-04 under 510(k) number K862665. The device is classified under product code KDT. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVACYTE-U?

NOVACYTE-U is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Xsirius Medical, Inc.. The 510(k) number is K862665.

When did NOVACYTE-U receive FDA 510(k) clearance?

NOVACYTE-U received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862665.

Who is the listed applicant for NOVACYTE-U?

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

What is the FDA product code for NOVACYTE-U?

The FDA product code for NOVACYTE-U is KDT.

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Related Devices (Code: KDT)

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.

K873593BIOSURE SPECIMEN COLLECTION CONTAINERBiosure, Inc.K834579BIOSPAL 2400SHospal Medical Corp.K834412PRESERV PVA FIXATIVE 15ML-FORMALIN PKPreventive Diagnostics Corp.K833660PRESERV PVA FIXATIVE -MALIN PACKPreventive Diagnostics Corp.K823773PROVIAL II #006-010-0201Dynatech Corp.K822870STOOL-COLLECTION/PRESERVATION KITAmerican Scientific Products

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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