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510(k) K770398

MINICON by Amicon, Inc. — Product Code JJH

K770398 is an FDA 510(k) premarket notification submitted by Amicon, Inc. for the device "MINICON". The FDA issued a decision of Substantially Equivalent on April 6, 1977. 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
April 6, 1977
Date Received
March 2, 1977
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)
  • 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 JJH

  • K113731 — ESENSOR RESPIRATORY VIRAL PANEL (September 10, 2012)
  • K960298 — VIVASPIN 4 10,000 MW (March 19, 1996)
  • K943966 — VIVAPORE 2 (April 11, 1995)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K935496 — NANOSEP N10 (April 26, 1994)
  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)

FDA data resources