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