ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)

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-skin Antibody Test(monkey Esophagus Sections).

Pre-market Notification Details

• Device ID: K891098
• 510k Number: K891098
• Device Name: ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
• Classification: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
• Applicant: IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223
• Contact: Russell Nisengard
• Correspondent: Russell Nisengard; 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: 1989-03-02
• Decision Date: 1989-03-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845714003714	K891098	000
00845714003707	K891098	000
00845714003660	K891098	000
00845714003561	K891098	000
00845714003257	K891098	000