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510(k) K812533

PLATELET AGITATOR by Helmer Labs, Inc. — Product Code KSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1981
Date Received
September 2, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Blood Mixing And Blood Weighing
Device Class
Class I
Regulation Number
864.9195
Review Panel
HE
Submission Type

Other clearances by Helmer Labs, Inc.

  • K802608 — HEMATIC BLOOD MIXER (December 11, 1980)
  • K770830 — PLATELET AGITATOR (July 11, 1977)

Other clearances for product code KSQ

  • K842746 — HYCEL ROTOR-MIXER AND/OR MULTI (August 17, 1984)
  • K820712 — SEPCOR UNIT COLLECTION MONITOR (May 7, 1982)
  • K810617 — MOBILE MATIC AUTOMATIC DONOR SCALE (April 7, 1981)
  • K802608 — HEMATIC BLOOD MIXER (December 11, 1980)
  • K800104 — ROYCO MODEL 951 CELL MIXER (February 6, 1980)
  • K780189 — PLATELET ROTATOR (March 30, 1978)
  • K760743 — DONORMATIC (BLOOD COLLECTION DEVICE) (December 6, 1976)