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510(k) K932424

ANA PROFILE I by Apotex Scientific, Inc. — Product Code LJM

K932424 is an FDA 510(k) premarket notification submitted by Apotex Scientific, Inc. for the device "ANA PROFILE I". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1993
Date Received
May 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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FDA data resources