The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Sceptor System Panels.
| Device ID | K950123 |
| 510k Number | K950123 |
| Device Name: | SCEPTOR SYSTEM PANELS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS 250 SCHILLING CIRCLE Cockeysville, MD 21030 -0243 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BECTON DICKINSON MICROBIOLOGY SYSTEMS 250 SCHILLING CIRCLE 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 | 1995-01-12 |
| Decision Date | 1995-03-23 |