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510(k) K820455

CENTRIFREE MICROPARTITION SYSTEM by Amicon, Inc. — Product Code JRL

K820455 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "CENTRIFREE MICROPARTITION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 15, 1982. The device falls under product code JRL (Unit, Filter, Membrane), 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
March 15, 1982
Date Received
February 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Filter, Membrane
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)

Other clearances for product code JRL

  • K822121 — ACRO PACK (August 5, 1982)
  • K820224 — EMIT FREELEVEL SYSTEM I (February 23, 1982)
  • K812750 — IL 703, STAT SEPARATOR (January 26, 1982)
  • K813159 — VACUSHIELD TM (December 8, 1981)
  • K810829 — ACRODISC (April 8, 1981)
  • K801500 — ULTRAFREE CALCIUM FILTER (August 20, 1980)
  • K790445 — ULTRA-FREE (June 28, 1979)
  • K781043 — CEA-IMMERSIBLE SEPARATOR (September 15, 1978)

FDA data resources