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510(k) K963803

CENTOCOR CA 15-3 RIA MODEL NO. 800-033 by Centocor, Inc. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1997
Date Received
September 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Centocor, Inc.

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