The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Cmv Latex Agglutination Test Kit.
| Device ID | K841520 |
| 510k Number | K841520 |
| Device Name: | CMV LATEX AGGLUTINATION TEST KIT |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-12 |
| Decision Date | 1984-09-07 |