Centocor Ca 15-3 Ria Model No. 800-033

FDA 510(k) K963803 · Centocor, Inc.

Substantially Equivalent

510(k) numberK963803

Submission

Device name
Centocor Ca 15-3 Ria Model No. 800-033
Applicant
Centocor, Inc.
Malvern, PA, US
Received
September 23, 1996
Decision date
May 23, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOI – System, Test, Immunological, Antigen, Tumor
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Specialty
Immunology

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Questions and answers

When was Centocor Ca 15-3 Ria Model No. 800-033 cleared by the FDA?

Centocor Ca 15-3 Ria Model No. 800-033 (K963803) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 242 days after the submission was received.

What is the product code of K963803?

The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.