AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

Ferritin, Antigen, Antiserum, Control

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ferritin Assay (additional Protocol).

Pre-market Notification Details

• Device ID: K892362
• 510k Number: K892362
• Device Name: AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
• Classification: Ferritin, Antigen, Antiserum, Control
• Applicant: AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005
• Contact: Frank J Lyman
• Correspondent: Frank J Lyman; AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005
• Product Code: DBF
• CFR Regulation Number: 866.5340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-04-06
• Decision Date: 1989-05-09