The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Vitamin B12/folate Dual Radioassay Kits.
Device ID | K812979 |
510k Number | K812979 |
Device Name: | VITAMIN B12/FOLATE DUAL RADIOASSAY KITS |
Classification | Acid, Folic, Radioimmunoassay |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGN |
CFR Regulation Number | 862.1295 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-23 |
Decision Date | 1981-11-24 |