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 |