MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94— 510(k) K852482

Name: FDA 510(k) clearance K852482
Creator: U.S. Food and Drug Administration
Published: 1985-07-15

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K852482 for MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94, Substantially Equivalent on 1985-07-15. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1985-06-11
Decision date: 1985-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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