The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Ferritin Controls Code Qas.104.
Device ID | K800657 |
510k Number | K800657 |
Device Name: | FERRITIN CONTROLS CODE QAS.104 |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-25 |
Decision Date | 1980-04-16 |