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510(k) K862665

NOVACYTE-U by Xsirius Medical, Inc. — Product Code KDT

K862665 is an FDA 510(k) premarket notification submitted by Xsirius Medical, Inc. for the device "NOVACYTE-U". The FDA issued a decision of Substantially Equivalent on September 4, 1986. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1986
Date Received
July 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type

Other clearances for product code KDT

  • K873593 — BIOSURE SPECIMEN COLLECTION CONTAINER (November 25, 1987)
  • K834579 — BIOSPAL 2400S (February 4, 1984)
  • K834412 — PRESERV PVA FIXATIVE 15ML-FORMALIN PK (January 13, 1984)
  • K833660 — PRESERV PVA FIXATIVE -MALIN PACK (November 28, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K822870 — STOOL-COLLECTION/PRESERVATION KIT (November 1, 1982)
  • K821621 — PREGNOPOST (July 21, 1982)
  • K820246 — PREFILLED SPECIMEN CONTAINER (February 18, 1982)
  • K811793 — FIX-RIGHT 90ML & 180 ML PREFILLED CONT (July 31, 1981)
  • K800946 — URINARY CATHETER SAMPLING KIT (June 20, 1980)

FDA data resources