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510(k) K821834

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

K821834 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "MODEL 100 BICARBONATE CONDUCTIVITY". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.

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.

  • K834024 — HEPARINOMETER (June 11, 1984)
  • K830468 — MODEL 200 (April 12, 1983)
  • 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)

Other clearances for product code FKQ

  • K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER (June 9, 2006)
  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • 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)

FDA data resources