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510(k) K200865

Piccolo Potassium Test System by Abaxis, Inc. — Product Code MZV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2021
Date Received
April 1, 2020
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, System, Potassium, Enzymatic Method
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

Other clearances by Abaxis, Inc.

  • K130113 — PICCOLO LACTATE TEST SYSTEM (March 11, 2013)
  • K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (February 15, 2013)
  • K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K091910 — PICCOLO MAGNESIUM TEST SYSTEM (October 1, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)
  • K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (January 24, 2003)
  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)

Other clearances for product code MZV

  • K091455 — DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQ (August 14, 2009)
  • K053566 — MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (February 15, 2006)
  • K042191 — DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (October 29, 2004)