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510(k) K872912

TRIGLYCERIDE (UV) REAGENT by Sigma Chemical Co. — Product Code JGW

K872912 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "TRIGLYCERIDE (UV) REAGENT". The FDA issued a decision of Substantially Equivalent on August 17, 1987. The device falls under product code JGW (Fluorometric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1987
Date Received
July 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code JGW

  • K852556 — TDX REA TRIGLYCERIDES (July 22, 1985)
  • K780439 — PRECIMAT GLYCEROL (April 18, 1978)

FDA data resources