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510(k) K971324

TRIGLYCERIDES, TG, OR TRIG by Carolina Liquid Chemistries Corp. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1997
Date Received
April 10, 1997
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 Carolina Liquid Chemistries Corp.

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  • K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS (May 16, 2014)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K972073 — TOTAL BILIRUBIN REAGENT (June 24, 1997)
  • K971907 — CALCIUM REAGENT (June 24, 1997)
  • K971967 — BUN (June 17, 1997)
  • K971908 — CREA OR CREATININE (June 17, 1997)
  • K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (June 16, 1997)
  • K971345 — CHOL OR CHOLESTEROL (May 29, 1997)
  • K971396 — CK REAGENT (May 29, 1997)

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  • 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)
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  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
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