The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Phase Ii Fsh Kit.
| Device ID | K883279 |
| 510k Number | K883279 |
| Device Name: | PHASE II FSH KIT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | VITEK SYSTEMS, INC. 273 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Ken Hoffman |
| Correspondent | Ken Hoffman VITEK SYSTEMS, INC. 273 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-03 |
| Decision Date | 1988-09-09 |