The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Bbl Crystal Mrsa Id System.
| Device ID | K941997 |
| 510k Number | K941997 |
| Device Name: | BBL CRYSTAL MRSA ID SYSTEM |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Robert E James |
| Correspondent | Robert E James BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1995-01-27 |