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510(k) K120664

PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM by Abaxis, Inc. — Product Code JGY

K120664 is an FDA 510(k) premarket notification submitted by Abaxis, Inc. for the device "PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 24, 2012. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Abaxis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2012
Date Received
March 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
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)
  • 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)
  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)
  • K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (January 24, 2003)

Other clearances for product code JGY

  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)
  • K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS (July 3, 2000)
  • K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS (May 24, 2000)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K954187 — TRIGLYCERIDES REAGENT (October 23, 1995)
  • K941063 — DNA TRIGLYCERIDE PROCEDURE (July 20, 1994)
  • K931116 — IL TEST(TM) TRIGLYCERIDE (March 28, 1994)
  • K914033 — CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (September 27, 1991)
  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)
  • K902202 — DMA TRIGLYCERIDE (GPO) PROCEDURE (July 31, 1990)

FDA data resources