The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Enterococcus Screening Medium.
| Device ID | K951539 |
| 510k Number | K951539 |
| Device Name: | ENTEROCOCCUS SCREENING MEDIUM |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith 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 | 1995-04-03 |
| Decision Date | 1995-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902222041 | K951539 | 000 |
| 30382902222010 | K951539 | 000 |