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510(k) K914123

SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS by Serim Research Corp. — Product Code LIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1992
Date Received
September 13, 1991
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

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  • 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)