CARDIZYME PLUS LD #65094/93— 510(k) K832314

Name: FDA 510(k) clearance K832314
Creator: U.S. Food and Drug Administration
Published: 1983-09-01

Substantially Equivalent

Em Industries, Inc.

FDA 510(k) clearance K832314 for CARDIZYME PLUS LD #65094/93, Substantially Equivalent on 1983-09-01. Applicant: Em Industries, Inc.. Device class: 2.

Clearance details

Applicant: Em Industries, Inc.
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1983-07-14
Decision date: 1983-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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