SPECTRASCAN

Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

MEDISHIELD, INC.

The following data is part of a premarket notification filed by Medishield, Inc. with the FDA for Spectrascan.

Pre-market Notification Details

• Device ID: K781103
• 510k Number: K781103
• Device Name: SPECTRASCAN
• Classification: Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
• Applicant: MEDISHIELD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DAT
• CFR Regulation Number: 864.7340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-07-03
• Decision Date: 1978-09-27