The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Simultrac Lh/fsh Radioummunoassay Kit.
| Device ID | K942638 |
| 510k Number | K942638 |
| Device Name: | SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 13 MOUNTAIN VIEW AVE. Orangeburg, NY 10962 |
| Contact | Kathy Biehl |
| Correspondent | Kathy Biehl BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 13 MOUNTAIN VIEW AVE. Orangeburg, NY 10962 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1994-09-07 |