Home / 510(k) Clearances / K992132

510(k) K992132

CHOLESITE TEST SYSTEM by Gds Technology, LLC — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1999
Date Received
June 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by Gds Technology, LLC

  • K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARD (February 11, 2002)
  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K973649 — HEMOSITE TEST SYSTEM (August 31, 1998)
  • K971145 — GLUCOSITE TEST SYSTEM (September 17, 1997)
  • K911801 — KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (July 1, 1991)
  • K882038 — GDS ENZYMATIC SALICYLATE REAGENT (June 24, 1988)
  • K880829 — GDS ENZYMATIC ACETAMINOPHEN REAGENT (May 27, 1988)

Other clearances for product code CHH

  • K251091 — Lipids (December 30, 2025)
  • K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (August 9, 2024)
  • K203597 — Cholesterol2 (June 30, 2022)
  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • K181373 — Extended Lipid Panel Assay (October 18, 2018)
  • K180504 — Mission Lipid Panel Monitoring System (March 28, 2018)
  • K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (July 11, 2017)
  • K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test Sys (December 22, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)