SED-FIX CONCENTRATE— 510(k) K852045

Name: FDA 510(k) clearance K852045
Creator: U.S. Food and Drug Administration
Published: 1985-06-10

Substantially Equivalent

Surgipath Medical Industries, Inc.

FDA 510(k) clearance K852045 for SED-FIX CONCENTRATE, Substantially Equivalent on 1985-06-10. Applicant: Surgipath Medical Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgipath Medical Industries, Inc.
Product code: Code IER
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1985-05-09
Decision date: 1985-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayslake, IL, US

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