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510(k) K091910

PICCOLO MAGNESIUM TEST SYSTEM by Abaxis, Inc. — Product Code JGJ

K091910 is an FDA 510(k) premarket notification submitted by Abaxis, Inc. for the device "PICCOLO MAGNESIUM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 2009. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Abaxis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2009
Date Received
June 25, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Magnesium
Device Class
Class I
Regulation Number
862.1495
Review Panel
CH
Submission Type

Other clearances by Abaxis, Inc.

  • K200865 — Piccolo Potassium Test System (October 20, 2021)
  • 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)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)
  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)
  • K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (January 24, 2003)

Other clearances for product code JGJ

  • K181748 — Magnesium (September 12, 2018)
  • K173294 — Magnesium (May 18, 2018)
  • K162200 — Randox RX Daytona Plus Magnesium (MG) (April 28, 2017)
  • K162399 — Atellica CH Magnesium (Mg) (January 19, 2017)
  • K122302 — ACE MAGNESIUM REGENT (August 27, 2012)
  • K111915 — MAGNESIUM ASSAY (December 2, 2011)
  • K092737 — EASYRA MG REAGENT, MODEL 10220 (November 17, 2009)
  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (January 19, 2007)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)

FDA data resources