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510(k) K801303

MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST by Western Laboratories Corp. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Western Laboratories Corp.

  • K834024 — HEPARINOMETER (June 11, 1984)
  • K830468 — MODEL 200 (April 12, 1983)
  • K821834 — MODEL 100 BICARBONATE CONDUCTIVITY (July 2, 1982)
  • K821414 — MODEL 80 BC (May 27, 1982)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K780932 — MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (August 31, 1978)

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  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)