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510(k) K900280

CENTRIPREP 100 by Amicon, Inc. — Product Code JJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
January 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Selective (Non-Specified)
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Amicon, Inc.

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  • K901286 — AMICON HEMOCONCENTRATOR SET (May 18, 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)
  • K853510 — MINIFILTER HEMOFILTER (September 12, 1985)

Other clearances for product code JJP

  • K863438 — NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER (September 29, 1986)
  • K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (February 10, 1986)