ANTI-ENDOMYSIAL ANTIBODY TEST

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

IMMCO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-endomysial Antibody Test.

Pre-market Notification Details

• Device ID: K912551
• 510k Number: K912551
• Device Name: ANTI-ENDOMYSIAL ANTIBODY TEST
• Classification: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
• Applicant: IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223
• Contact: Susan Krasny
• Correspondent: Susan Krasny; IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223
• Product Code: DBL
• CFR Regulation Number: 866.5660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-06-11
• Decision Date: 1993-06-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845714003646	K912551	000
00845714003066	K912551	000
00845714003059	K912551	000