Imx Ca 15-3

FDA 510(k) K964407 · Abbott Laboratories

Substantially Equivalent

510(k) numberK964407

Submission

Device name
Imx Ca 15-3
Applicant
Abbott Laboratories
Abbott Park, IL, US
Received
November 4, 1996
Decision date
November 10, 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 Imx Ca 15-3 cleared by the FDA?

Imx Ca 15-3 (K964407) received a 510(k) decision of Substantially Equivalent on November 10, 1997, 371 days after the submission was received.

What is the product code of K964407?

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