Home / 510(k) Clearances / K771904

510(k) K771904

GLYCEROL KINASE by Simmler & Son, Inc. — Product Code CDT

K771904 is an FDA 510(k) premarket notification submitted by Simmler & Son, Inc. for the device "GLYCEROL KINASE". The FDA issued a decision of Substantially Equivalent on December 6, 1977. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Simmler & Son, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1977
Date Received
October 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Simmler & Son, Inc.

  • K780817 — GLOBIN-TERGE (July 27, 1978)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760476 — REAGENT, LACTATE DEHYDROGENASE (November 1, 1976)
  • K760479 — REAGENT, TOTAL BILIRUBIN DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)
  • K760477 — REAGENTS-4 FOR URIC ACID DETERMINATION (October 29, 1976)
  • K760474 — REAGENT, ALKALINE PHOSPHATASE DETERM. (October 29, 1976)

Other clearances for product code CDT

  • K150819 — Triglycerides (August 6, 2015)
  • K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (November 22, 2013)
  • K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES (May 31, 2013)
  • K113830 — VANTERA CLINICAL ANALYZER (August 30, 2012)
  • K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL (May 19, 2011)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (January 18, 2005)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K010871 — TGL FLEX REAGENT CARTRIDGE (July 9, 2001)

FDA data resources