The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Micromedic Combostat B B12/folate(boil).
| Device ID | K853127 |
| 510k Number | K853127 |
| Device Name: | MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) |
| Classification | Radioassay, Vitamin B12 |
| Applicant | MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Contact | John M Kauffman |
| Correspondent | John M Kauffman MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-25 |
| Decision Date | 1985-09-16 |