ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

Anti-dna Antibody (enzyme-labeled), Antigen, Control

HELIX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Anti-double Stranded Dna (dsdna) Test Kit.

Pre-market Notification Details

• Device ID: K960091
• 510k Number: K960091
• Device Name: ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
• Classification: Anti-dna Antibody (enzyme-labeled), Antigen, Control
• Applicant: HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221
• Contact: Virginia L Cappel
• Correspondent: Virginia L Cappel; HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221
• Product Code: LRM
• CFR Regulation Number: 866.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-01-11
• Decision Date: 1996-03-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847817022364	K960091	000
00847817007040	K960091	000
00847817007033	K960091	000
00847817006937	K960091	000