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510(k) K934046

BECKMAN CHOLESTEROL REAGENT by Beckman-Diagnostic Systems Group — Product Code CHH

K934046 is an FDA 510(k) premarket notification submitted by Beckman-Diagnostic Systems Group for the device "BECKMAN CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on October 28, 1993. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Beckman-Diagnostic Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1993
Date Received
August 19, 1993
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 Beckman-Diagnostic Systems Group

  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K944605 — CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM (December 7, 1994)
  • K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (December 7, 1994)
  • K944606 — CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (November 30, 1994)
  • K942676 — SYNCHRON CX3 DELTA (November 2, 1994)
  • K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (July 6, 1994)
  • K934068 — BECKMAN DIRECT BILIRUBIN REAGENT (April 26, 1994)
  • K936184 — VIGIL PRX CHEMISTRY CONTROL (April 15, 1994)
  • K934271 — BECKMAN SYNCHRON LACTATE REAGENT (November 9, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 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