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510(k) K801012

TRIGLYCERIDE REAGENT (COLOR) by Gilford Diagnostics — Product Code JGY

K801012 is an FDA 510(k) premarket notification submitted by Gilford Diagnostics for the device "TRIGLYCERIDE REAGENT (COLOR)". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Gilford Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 28, 1980
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 Gilford Diagnostics

  • K832094 — BILIRUBIN CALIBRATORS & CONTROL (August 11, 1983)
  • K831844 — DIRECT BILIRUBIN REAGENT (July 18, 1983)
  • K831843 — GILCHEM TOTAL BILIRUBIN REAGENT (July 18, 1983)
  • K823709 — TRIGLYCERIDE REAGENT (UV) (January 7, 1983)
  • K822739 — AHBD (October 18, 1982)
  • K822334 — BILIRUBIN CALIBRATORS (September 2, 1982)
  • K822289 — CO2/CI STANDARDS (August 24, 1982)
  • K822149 — GILCHEM Y-GT REAGENT (August 12, 1982)
  • K821719 — AMMONIA REAGENT (June 24, 1982)
  • K820976 — GIL CHEM MAGNESIUM REAGENT (April 26, 1982)

Other clearances for product code JGY

  • K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (April 24, 2012)
  • 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)

FDA data resources