POLYSTAT, BIOLOGICAL STAIN— 510(k) K844640

Name: FDA 510(k) clearance K844640
Creator: U.S. Food and Drug Administration
Published: 1985-01-30

Substantially Equivalent

Surgipath Medical Industries, Inc.

FDA 510(k) clearance K844640 for POLYSTAT, BIOLOGICAL STAIN, Substantially Equivalent on 1985-01-30. Applicant: Surgipath Medical Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgipath Medical Industries, Inc.
Product code: Code IAB
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1984-11-28
Decision date: 1985-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayslake, IL, US

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