The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Rubascan Card Test.
| Device ID | K952721 |
| 510k Number | K952721 |
| Device Name: | RUBASCAN CARD TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 987 Columbus, NE 68602 -0987 |
| Contact | Robert E James |
| Correspondent | Robert E James BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 987 Columbus, NE 68602 -0987 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1996-12-20 |
| Summary: | summary |