H-103 IGG, H-104 IGA, H-105 IGM

Igg (gamma Chain Specific), Antigen, Antiserum, Control

IMMULOK, INC.

The following data is part of a premarket notification filed by Immulok, Inc. with the FDA for H-103 Igg, H-104 Iga, H-105 Igm.

Pre-market Notification Details

• Device ID: K812821
• 510k Number: K812821
• Device Name: H-103 IGG, H-104 IGA, H-105 IGM
• Classification: Igg (gamma Chain Specific), Antigen, Antiserum, Control
• Applicant: IMMULOK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DFZ
• CFR Regulation Number: 866.5510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-10-07
• Decision Date: 1981-10-26