The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Linezolid Antimicrobial Susceptibility Test Disc.
| Device ID | K010537 |
| 510k Number | K010537 |
| Device Name: | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Contact | Amanda Sheppard |
| Correspondent | Amanda Sheppard OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-23 |
| Decision Date | 2001-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384097623 | K010537 | 000 |