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510(k) K800104

ROYCO MODEL 951 CELL MIXER by Royco Instruments — Product Code KSQ

K800104 is an FDA 510(k) premarket notification submitted by Royco Instruments for the device "ROYCO MODEL 951 CELL MIXER". The FDA issued a decision of Substantially Equivalent on February 6, 1980. The device falls under product code KSQ (Device, Blood Mixing And Blood Weighing), a Class I device regulated under 21 CFR 864.9195. Royco Instruments has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1980
Date Received
January 16, 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 Royco Instruments

  • K791867 — ROYCO MODEL 921 CELL COUNTER (November 5, 1979)
  • K791644 — ROYCO MODEL 371 SUPER DILUTOR (September 19, 1979)
  • K790442 — ISOTONIC DILUENT (April 4, 1979)

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)
  • K802608 — HEMATIC BLOOD MIXER (December 11, 1980)
  • K780189 — PLATELET ROTATOR (March 30, 1978)
  • K760743 — DONORMATIC (BLOOD COLLECTION DEVICE) (December 6, 1976)

FDA data resources