The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Precise Pregnancy.
| Device ID | K930640 |
| 510k Number | K930640 |
| Device Name: | PRECISE PREGNANCY |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 10 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 10 LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-28 |
| Decision Date | 1993-03-18 |