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 |