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510(k) K802608

HEMATIC BLOOD MIXER by Helmer Labs, Inc. — Product Code KSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
October 21, 1980
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.

  • K812533 — PLATELET AGITATOR (September 29, 1981)
  • 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)
  • K812533 — PLATELET AGITATOR (September 29, 1981)
  • K810617 — MOBILE MATIC AUTOMATIC DONOR SCALE (April 7, 1981)
  • K800104 — ROYCO MODEL 951 CELL MIXER (February 6, 1980)
  • K780189 — PLATELET ROTATOR (March 30, 1978)
  • K760743 — DONORMATIC (BLOOD COLLECTION DEVICE) (December 6, 1976)