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510(k) K191496

TDS Standard Solution by Mesa Laboratories, Inc. — Product Code FKH

K191496 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "TDS Standard Solution". The FDA issued a decision of Substantially Equivalent on August 5, 2019. The device falls under product code FKH (Solution-Test Standard-Conductivity, Dialysis), a Class II device regulated under 21 CFR 876.5820. Mesa Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2019
Date Received
June 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution-Test Standard-Conductivity, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Mesa Laboratories, Inc.

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K140589 — STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (December 3, 2014)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K122362 — SMART-WELL INCUBATOR (March 26, 2013)
  • K112018 — SMART READ EZTEST STEAM (January 30, 2012)
  • K050812 — 90XL INSTRUMENTATION SYSTEM (May 5, 2005)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)

Other clearances for product code FKH

  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION (July 2, 2004)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)
  • K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE (September 17, 2003)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)
  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)
  • K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET (September 24, 1981)

FDA data resources