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510(k) K870828

INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT by Intersect Systems, Inc. — Product Code CHH

K870828 is an FDA 510(k) premarket notification submitted by Intersect Systems, Inc. for the device "INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on March 13, 1987. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Intersect Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
March 3, 1987
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 Intersect Systems, Inc.

  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K011972 — DIRECT BILIRUBIN REAGENT (August 27, 2001)
  • K011692 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (July 25, 2001)
  • K003892 — TOTAL BILIRUBIN REAGENT (February 20, 2001)
  • K983937 — DUAL VIAL CREATININE REAGENT (January 6, 1999)
  • K974833 — CK-NAC REAGENT (February 13, 1998)
  • K941807 — INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (September 14, 1994)
  • K932888 — INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (January 31, 1994)
  • K934039 — INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (November 16, 1993)
  • K932267 — ENZYMATIC CO2 REAGENT, MODIFICATION (September 24, 1993)

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)

FDA data resources