COULTER HDL CHOLESTEROL REAG. SYSTEM— 510(k) K792319

Name: FDA 510(k) clearance K792319
Creator: U.S. Food and Drug Administration
Published: 1979-12-06

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K792319 for COULTER HDL CHOLESTEROL REAG. SYSTEM, Substantially Equivalent on 1979-12-06. Applicant: Coulter Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1979-11-19
Decision date: 1979-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17

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