Diastat Anti-Sm

FDA 510(k) K905191 · Shield Diagnostics, Ltd.

Substantially Equivalent

510(k) numberK905191

Submission

Device name
Diastat Anti-Sm
Applicant
Shield Diagnostics, Ltd.
Scotland, KN
Received
November 19, 1990
Decision date
December 7, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LKP – Anti-Sm Antibody, Antigen And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

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Questions and answers

When was Diastat Anti-Sm cleared by the FDA?

Diastat Anti-Sm (K905191) received a 510(k) decision of Substantially Equivalent on December 7, 1990, 18 days after the submission was received.

What is the product code of K905191?

The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.