IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS

System, Test, Anticardiolipin Immunological

IMMCO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced (tm) Cardiolipin Iga, Igg, Igm And Iga/igg/igm Antibody (aca) Elisas.

Pre-market Notification Details

• Device ID: K113020
• 510k Number: K113020
• Device Name: IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
• Classification: System, Test, Anticardiolipin Immunological
• Applicant: IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120
• Contact: Kevin J Lawson
• Correspondent: Kevin J Lawson; IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120
• Product Code: MID
• CFR Regulation Number: 866.5660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-11
• Decision Date: 2012-10-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845714002823	K113020	000