IFA ANTI-NDNA

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Ifa Anti-ndna.

Pre-market Notification Details

• Device ID: K771376
• 510k Number: K771376
• Device Name: IFA ANTI-NDNA
• Classification: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
• Applicant: ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DHN
• CFR Regulation Number: 866.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-07-25
• Decision Date: 1977-10-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G5229024201	K771376	000