VIRGO REAGENTS INDIRECT FLUORSCENT

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 Virgo Reagents Indirect Fluorscent.

Pre-market Notification Details

• Device ID: K841127
• 510k Number: K841127
• Device Name: VIRGO REAGENTS INDIRECT FLUORSCENT
• Classification: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
• Applicant: ELECTRO-NUCLEONICS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DHN
• CFR Regulation Number: 866.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-03-16
• Decision Date: 1984-04-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G5229023901	K841127	000
G5229023701	K841127	000
G5229023601	K841127	000
G5229023451	K841127	000
G5229023441	K841127	000