Home / 510(k) Clearances / K894057

510(k) K894057

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT by Photec Diagnostics, Inc. — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1989
Date Received
June 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Photec Diagnostics, Inc.

  • K897169 — QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (February 23, 1990)
  • K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (December 12, 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)

Other clearances for product code LBS

  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES (September 7, 2012)
  • K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER (September 27, 2011)
  • K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL (August 31, 2011)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)
  • K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
  • K100010 — HDL CHOLESTEROL (HDLX) ASSAY (May 14, 2010)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)