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510(k) K832230

DIALYZER PREPARATION SYS DPS-4 by Seratronics, Inc. — Product Code LIF

K832230 is an FDA 510(k) premarket notification submitted by Seratronics, Inc. for the device "DIALYZER PREPARATION SYS DPS-4". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Seratronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
July 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Seratronics, Inc.

  • K955299 — DPS 4 DIALYZER PREPARATION SYSTEM (October 21, 1996)
  • K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM (April 18, 1996)
  • K944539 — DRS 4 ND DIALYZER REPROCESSING SYSTEM (November 29, 1995)
  • K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES (August 29, 1994)
  • K914580 — DRS-4 DIALYZER REPROCESSING SYSTEM (February 24, 1992)
  • K874573 — FRESENIUS PURISTERIL 340 (TM) (April 25, 1988)
  • K874872 — FRESENIUS HEMOFLOW F3, F4, F5, F7 (February 19, 1988)
  • K870725 — FRESENIUS HEMOFLOW F6 AND F8 (May 1, 1987)
  • K870724 — FRESENIUS HEMOFLOW F60 AND F80 (April 1, 1987)
  • K864587 — FRESENIUS ULTRAFLUX AV400, AV600 (March 3, 1987)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)

FDA data resources