NOVACYTE-U— 510(k) K862665

Substantially Equivalent

Xsirius Medical, Inc.

FDA 510(k) clearance K862665 for NOVACYTE-U, Substantially Equivalent on 1986-09-04. Applicant: Xsirius Medical, Inc.. Device class: 1.

Clearance details

Applicant: Xsirius Medical, Inc.
Product code: Code KDT
Device class: Class 1
Regulation: 21 CFR 864.3250
Advisory panel: Pathology
Date received: 1986-07-14
Decision date: 1986-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rolling Hills Estates, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDT

K873593 — BIOSURE SPECIMEN COLLECTION CONTAINER1987-11-25
K834579 — BIOSPAL 2400S1984-02-04
K834412 — PRESERV PVA FIXATIVE 15ML-FORMALIN PK1984-01-13
K833660 — PRESERV PVA FIXATIVE -MALIN PACK1983-11-28
K823773 — PROVIAL II #006-010-02011983-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.