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510(k) K801219

PLASMAPOOLER by North American Biologicals, Inc. — Product Code KSR

K801219 is an FDA 510(k) premarket notification submitted by North American Biologicals, Inc. for the device "PLASMAPOOLER". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. North American Biologicals, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
May 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type

Other clearances by North American Biologicals, Inc.

  • K820301 — PLASMA POOLER HEAT SEALER (April 9, 1982)
  • K801425 — RH CONTROL (July 14, 1980)
  • K781895 — BLOOD GROUP SUBSTANCE B (December 20, 1978)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)

Other clearances for product code KSR

  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K810500 — BLOOD FREEZING BAG (September 23, 1981)
  • K811523 — PLASMA FLEX (September 9, 1981)
  • K811449 — HAEMONETICS 1000ML COMPONENT BAG (July 1, 1981)
  • K810711 — HAEMONETICS 600 ML. COMPONENT BAG (May 8, 1981)
  • K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAG (March 31, 1981)
  • K801082 — GAMBRO HEMOFREEZE-BAG (October 31, 1980)
  • K792395 — PHARMAFLEX CRYOGENIC BAG (February 26, 1980)

FDA data resources