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510(k) K893733

CENTRICON CONCENTRATOR by Amicon, Inc. — Product Code JJH

K893733 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "CENTRICON CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on July 20, 1989. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310. Amicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1989
Date Received
May 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clinical Sample Concentrator
Device Class
Class I
Regulation Number
862.2310
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)
  • 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 JJH

  • K113731 — ESENSOR RESPIRATORY VIRAL PANEL (September 10, 2012)
  • K960298 — VIVASPIN 4 10,000 MW (March 19, 1996)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K943966 — VIVAPORE 2 (April 11, 1995)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K935496 — NANOSEP N10 (April 26, 1994)
  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K851393 — DUPONT PREP FOUR-SOLVENT RETROFIT KIT (July 12, 1985)

FDA data resources