SEPRACELL LYMPHOCYTE SEPARATION MEDIUM— 510(k) K860354

Name: FDA 510(k) clearance K860354
Creator: U.S. Food and Drug Administration
Published: 1986-04-18

Substantially Equivalent

Sepratech Corporation C/O Keller and Heckman

FDA 510(k) clearance K860354 for SEPRACELL LYMPHOCYTE SEPARATION MEDIUM, Substantially Equivalent on 1986-04-18. Applicant: Sepratech Corporation C/O Keller and Heckman. Device class: 1.

Clearance details

Applicant: Sepratech Corporation C/O Keller and Heckman
Product code: Code JCF
Device class: Class 1
Regulation: 21 CFR 864.8500
Advisory panel: Hematology
Date received: 1986-01-30
Decision date: 1986-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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