The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii B-12/folate Kit.
| Device ID | K853224 |
| 510k Number | K853224 |
| Device Name: | PHASE II B-12/FOLATE KIT |
| Classification | Radioassay, Vitamin B12 |
| Applicant | MEDICAL & SCIENTIFIC DESIGNS, INC. 273 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Kenneth L Hoffman |
| Correspondent | Kenneth L Hoffman MEDICAL & SCIENTIFIC DESIGNS, INC. 273 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1985-10-03 |