AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY— 510(k) K892645

Name: FDA 510(k) clearance K892645
Creator: U.S. Food and Drug Administration
Published: 1989-06-13

Substantially Equivalent

Amicon, Inc.

FDA 510(k) clearance K892645 for AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY, Substantially Equivalent on 1989-06-13. Applicant: Amicon, Inc.. Device class: 1.

Clearance details

Applicant: Amicon, Inc.
Product code: Code KJF
Device class: Class 1
Regulation: 21 CFR 864.2240
Advisory panel: Hematology
Date received: 1989-04-12
Decision date: 1989-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.