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510(k) K905226

TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL by Enzyme Technology, Inc. — Product Code JGY

K905226 is an FDA 510(k) premarket notification submitted by Enzyme Technology, Inc. for the device "TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL". The FDA issued a decision of Substantially Equivalent on December 11, 1990. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Enzyme Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1990
Date Received
November 20, 1990
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 Enzyme Technology, Inc.

  • K912027 — CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL (January 30, 1992)
  • K912028 — URIC ACID (URICASE) REAGENT, UNIVERSAL (December 18, 1991)
  • K905227 — GLUCOSE (HK) REAGENT, UNIVERSAL (March 11, 1991)
  • K896073 — CHOLESTEROL, UNIVERSAL ET (December 12, 1989)

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)
  • K902202 — DMA TRIGLYCERIDE (GPO) PROCEDURE (July 31, 1990)

FDA data resources