ACUSYST-P (CELL CULTURE EQUIPMENT)— 510(k) K864334

Name: FDA 510(k) clearance K864334
Creator: U.S. Food and Drug Administration
Published: 1986-11-24

Substantially Equivalent

Endotronics, Inc.

FDA 510(k) clearance K864334 for ACUSYST-P (CELL CULTURE EQUIPMENT), Substantially Equivalent on 1986-11-24. Applicant: Endotronics, Inc.. Device class: 1.

Clearance details

Applicant: Endotronics, Inc.
Product code: Code KJH
Device class: Class 1
Regulation: 21 CFR 864.2240
Advisory panel: Hematology
Date received: 1986-11-04
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coon Rapids, MN, US

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Recent devices under product code KJH

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K875151 — ACUSYST-P/3X1988-01-12
K872086 — ACUSYST-JR1987-06-15

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