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510(k) K810810

AMICON ULTRAFILTRATION MEMBRANES CMII by Amicon, Inc. — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1981
Date Received
March 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Carcinoembryonic Antigen
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Amicon, Inc.

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  • K901286 — AMICON HEMOCONCENTRATOR SET (May 18, 1990)
  • K900280 — CENTRIPREP 100 (February 16, 1990)
  • K895405 — AMICON MINIFILTER PLUS HEMOFILTER (January 11, 1990)
  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K892645 — AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY (June 13, 1989)
  • K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM (February 19, 1988)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K863823 — AMICON DIAFILTER HEMOFILTER (November 6, 1986)

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