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510(k) K821834

MODEL 100 BICARBONATE CONDUCTIVITY by Western Laboratories Corp. — Product Code FKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
June 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Western Laboratories Corp.

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  • K821414 — MODEL 80 BC (May 27, 1982)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K801303 — MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST (July 28, 1980)
  • K780932 — MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (August 31, 1978)

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  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)