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510(k) K897169

QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT by Photec Diagnostics, Inc. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1990
Date Received
December 28, 1989
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 Photec Diagnostics, Inc.

  • K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (December 12, 1989)
  • K894057 — QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (August 31, 1989)
  • K892224 — D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN (June 16, 1989)
  • K890267 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA (April 26, 1989)
  • K890027 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD (April 26, 1989)
  • K882307 — D-CHEM (August 2, 1988)
  • K880291 — THEOPHYLLINE TEST KIT REF. #A874799 (March 24, 1988)
  • K854875 — APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (January 24, 1986)
  • K853048 — APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 (August 28, 1985)
  • K853174 — APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (August 22, 1985)

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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)
  • 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)