The following data is part of a premarket notification filed by Dickinson, And Co. with the FDA for Linezolid, 30ug, Bbl Sensi-disc.
| Device ID | K002165 |
| 510k Number | K002165 |
| Device Name: | LINEZOLID, 30UG, BBL SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | DICKINSON, AND CO. 7 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Bradford Spring |
| Correspondent | Bradford Spring DICKINSON, AND CO. 7 LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-18 |
| Decision Date | 2000-09-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902317616 | K002165 | 000 |
| 30382902317624 | K002165 | 000 |