The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Vancomycin Ii.
| Device ID | K955851 |
| 510k Number | K955851 |
| Device Name: | AXSYM VANCOMYCIN II |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Grace Lemieux |
| Correspondent | Grace Lemieux ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-27 |
| Decision Date | 1996-05-09 |
| Summary: | summary |