Home / 510(k) Clearances / K820447

510(k) K820447

ALPHA PLASMA TRANSFER SET by Alpha Therapeutic Corp. — Product Code KSB

K820447 is an FDA 510(k) premarket notification submitted by Alpha Therapeutic Corp. for the device "ALPHA PLASMA TRANSFER SET". The FDA issued a decision of Substantially Equivalent on April 14, 1982. The device falls under product code KSB (Set, Transfer (Blood/Plasma)), a Class II device regulated under 21 CFR 864.9875. Alpha Therapeutic Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
February 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Transfer (Blood/Plasma)
Device Class
Class II
Regulation Number
864.9875
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)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K810761 — ALPHA MICRON-40 FILTER (June 30, 1981)

Other clearances for product code KSB

  • K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System (September 28, 2018)
  • K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT (May 19, 2000)
  • K802940 — SUPER-SPIKE TRANSFER SET (January 15, 1981)
  • K791131 — FLU VEN TR-1 (September 4, 1979)
  • K791130 — FLU-VEN TK-2 (September 4, 1979)

FDA data resources