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510(k) K820712

SEPCOR UNIT COLLECTION MONITOR by Separation Science Corp. — Product Code KSQ

K820712 is an FDA 510(k) premarket notification submitted by Separation Science Corp. for the device "SEPCOR UNIT COLLECTION MONITOR". The FDA issued a decision of Substantially Equivalent on May 7, 1982. The device falls under product code KSQ (Device, Blood Mixing And Blood Weighing), a Class I device regulated under 21 CFR 864.9195. Separation Science Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1982
Date Received
March 15, 1982
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 Separation Science Corp.

  • K813327 — SEPCOR TEMPERATURE MONITOR (December 31, 1981)

Other clearances for product code KSQ

  • K842746 — HYCEL ROTOR-MIXER AND/OR MULTI (August 17, 1984)
  • 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)

FDA data resources