ENZYMATICS, INC., TOTAL CHOLESTEROL TEST— 510(k) K911692

Name: FDA 510(k) clearance K911692
Creator: U.S. Food and Drug Administration
Published: 1991-08-16

Substantially Equivalent

Enzymatics C/O Burditt,Bowles,Radzius & Ruberry

FDA 510(k) clearance K911692 for ENZYMATICS, INC., TOTAL CHOLESTEROL TEST, Substantially Equivalent on 1991-08-16. Applicant: Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. Device class: 1.

Clearance details

Applicant: Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1991-04-16
Decision date: 1991-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

Download summary PDF View on FDA.gov ↗

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