IIF-A-N-DNA TEST KIT

System, Test, Systemic Lupus Erythematosus

MEDICA CORP.

The following data is part of a premarket notification filed by Medica Corp. with the FDA for Iif-a-n-dna Test Kit.

Pre-market Notification Details

• Device ID: K790106
• 510k Number: K790106
• Device Name: IIF-A-N-DNA TEST KIT
• Classification: System, Test, Systemic Lupus Erythematosus
• Applicant: MEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DHC
• CFR Regulation Number: 866.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-01-18
• Decision Date: 1979-03-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00813545026592	K790106	000
00813545026585	K790106	000