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510(k) K130100

COMINED STANDARD SOLUTION by Mesa Laboratories, Inc. — Product Code FKH

K130100 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "COMINED STANDARD SOLUTION". The FDA issued a decision of Substantially Equivalent on April 18, 2013. 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
April 18, 2013
Date Received
January 15, 2013
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)
  • K191496 — TDS Standard Solution (August 5, 2019)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K140589 — STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (December 3, 2014)
  • 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

  • K191496 — TDS Standard Solution (August 5, 2019)
  • 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