The following data is part of a premarket notification filed by Diagnon Corp. with the FDA for Diagnon Monocombo Vitam. B12[57co]/folate[125i] Ra.
| Device ID | K851377 |
| 510k Number | K851377 |
| Device Name: | DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA |
| Classification | Radioassay, Vitamin B12 |
| Applicant | DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
| Contact | Marie T Perlstein |
| Correspondent | Marie T Perlstein DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-08 |
| Decision Date | 1985-08-21 |