The following data is part of a premarket notification filed by Becton Dickinson Advanced Diagnostics with the FDA for Precise Tm Hcg.
| Device ID | K915197 |
| 510k Number | K915197 |
| Device Name: | PRECISE TM HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BECTON DICKINSON ADVANCED DIAGNOSTICS 225 INTERNATIONAL CIRCLE Cockeysville, MD 21030 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BECTON DICKINSON ADVANCED DIAGNOSTICS 225 INTERNATIONAL CIRCLE Cockeysville, MD 21030 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-19 |
| Decision Date | 1991-12-17 |