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510(k) K761262

TRIGLYCERIDES (LIPASE) REAGENT SET by Worthington Biochemical Corp. — Product Code CDT

K761262 is an FDA 510(k) premarket notification submitted by Worthington Biochemical Corp. for the device "TRIGLYCERIDES (LIPASE) REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 29, 1976. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Worthington Biochemical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1976
Date Received
December 16, 1976
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 Worthington Biochemical Corp.

  • K780389 — HDL REAGENT SET FOR LIPOPROTEINS (April 19, 1978)
  • K780096 — LDH ISOENZYME CONTROL SERUM (March 3, 1978)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K772025 — URIC ACID STD. FOR QUANT. URIC ACID (November 11, 1977)
  • K771143 — INORGANIC PHOSPHORUS STANDARDS (July 11, 1977)
  • K770831 — STATZYME URIC ACID REAGENT (July 11, 1977)
  • K771001 — STATZYME GLUCOSE (July 11, 1977)
  • K770470 — WORTHINGTON BUN (June 2, 1977)
  • K770277 — CHOLESTEROL STANDARDS (March 1, 1977)
  • K761263 — CHOLESTEROL AUTOMATED REAGENT (December 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