ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)

Antinuclear Antibody, 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-native Dna Antibody Test (crithidia Luciliae).

Pre-market Notification Details

• Device ID: K884400
• 510k Number: K884400
• Device Name: ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
• Classification: Antinuclear Antibody, 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: DHN
• CFR Regulation Number: 866.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-10-19
• Decision Date: 1988-11-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845714003677	K884400	000
00845714003240	K884400	000