The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Phase Ii Lh Kit.
| Device ID | K882252 |
| 510k Number | K882252 |
| Device Name: | PHASE II LH KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Ken Hoffman |
| Correspondent | Ken Hoffman VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-31 |
| Decision Date | 1988-08-04 |