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510(k) K810897

ALPHA PLASTIC PLASMA BOTTLE by Alpha Therapeutic Corp. — Product Code KSR

K810897 is an FDA 510(k) premarket notification submitted by Alpha Therapeutic Corp. for the device "ALPHA PLASTIC PLASMA BOTTLE". The FDA issued a decision of Substantially Equivalent on September 23, 1981. 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. Alpha Therapeutic Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
April 3, 1981
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 Alpha Therapeutic Corp.

  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K854920 — THERAPY CASSETTS (May 19, 1986)
  • K854441 — STUART GILMAN'S WEIGHT LOSS PLAN (February 10, 1986)
  • K833294 — ALPHA Y-RECIPIENT SET (December 27, 1983)
  • K820447 — ALPHA PLASMA TRANSFER SET (April 14, 1982)
  • K810761 — ALPHA MICRON-40 FILTER (June 30, 1981)

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)
  • 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)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K792395 — PHARMAFLEX CRYOGENIC BAG (February 26, 1980)

FDA data resources