CENTOCOR CA 15-3 RIA MODEL NO. 800-033— 510(k) K963803

Name: FDA 510(k) clearance K963803
Creator: U.S. Food and Drug Administration
Published: 1997-05-23

Substantially Equivalent

Centocor, Inc.

FDA 510(k) clearance K963803 for CENTOCOR CA 15-3 RIA MODEL NO. 800-033, Substantially Equivalent on 1997-05-23. Applicant: Centocor, Inc.. Device class: 2.

Clearance details

Applicant: Centocor, Inc.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1996-09-23
Decision date: 1997-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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