Home / 510(k) Clearances / K761100

510(k) K761100

MULTI-CELL ULTRAFILTRATION SYSTEM by Amicon, Inc. — Product Code JQQ

K761100 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "MULTI-CELL ULTRAFILTRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 1976. The device falls under product code JQQ (Dialyzer), a Class I device regulated under 21 CFR 862.2050. Amicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1976
Date Received
November 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Amicon, Inc.

  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K902837 — AMICON DIAFILTER 30 HEMOCONCENTRATOR (November 1, 1990)
  • 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)

FDA data resources