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510(k) K834579

BIOSPAL 2400S by Hospal Medical Corp. — Product Code KDT

K834579 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "BIOSPAL 2400S". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
December 29, 1983
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 by Hospal Medical Corp.

  • K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER (July 24, 1989)
  • K884365 — MULTIFLOW(TM) 60 KIT (December 8, 1988)
  • K884326 — FILTRAL TM 8 HEMODIALYZER (December 5, 1988)
  • K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (October 12, 1988)
  • K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (December 29, 1987)
  • K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (April 30, 1987)
  • K863961 — HOSPAL BIOSPAL 1800S (December 17, 1986)
  • K863592 — DISSCAP 80E, 110E, 140E, 160E (September 25, 1986)
  • K861156 — HOSPAL DIALYSATE FOR CAVHD (September 23, 1986)
  • K861230 — MONITRAL S (April 25, 1986)

Other clearances for product code KDT

  • K873593 — BIOSURE SPECIMEN COLLECTION CONTAINER (November 25, 1987)
  • K862665 — NOVACYTE-U (September 4, 1986)
  • 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