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510(k) K842746

HYCEL ROTOR-MIXER AND/OR MULTI by R&D Systems, Inc. — Product Code KSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
July 13, 1984
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

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Other clearances for product code KSQ

  • K820712 — SEPCOR UNIT COLLECTION MONITOR (May 7, 1982)
  • K812533 — PLATELET AGITATOR (September 29, 1981)
  • 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)