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510(k) K914609

TRIGLYCERIDES REAGENT SET by Sterling Diagnostics, Inc. — Product Code CDT

K914609 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "TRIGLYCERIDES REAGENT SET". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
October 17, 1991
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 Sterling Diagnostics, Inc.

  • K921412 — MICROPROTEIN REAGENT SET (January 21, 1993)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K914040 — PHOSPHOLIPID REAGENT SET (October 30, 1991)
  • K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (July 29, 1986)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (July 1, 1986)
  • K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV) (July 1, 1986)
  • K862209 — ALT (SGPT) REAGENT SET (UV RATE) (June 25, 1986)
  • K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (June 16, 1986)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)

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