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510(k) K874034

ADR-22 AUTOMATIC DIALYZER REPROCESSOR by Biodynamics Corp. — Product Code LIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
October 5, 1987
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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  • K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (July 28, 1988)
  • K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER (March 16, 1988)
  • K873807 — AUTOTRANSFUSION APPARATUS (March 9, 1988)
  • K870052 — INFUMIX MIXING CONTAINER (February 27, 1987)
  • K822716 — UNIVERSAL CENTRIFUGE (September 30, 1982)
  • K822715 — PLATELET CENTRIFUGE (September 30, 1982)
  • K822422 — BASIC CENTRIFUGE (September 2, 1982)

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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)