Linezolid Antimicrobial Susceptibility Test Disc
FDA 510(k) K010537 · Oxoid , Ltd.
510(k) numberK010537
Submission
- Device name
- Linezolid Antimicrobial Susceptibility Test Disc
- Applicant
- Oxoid , Ltd.
Basingstoke, GB - Received
- February 23, 2001
- Decision date
- April 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1620
- Specialty
- Microbiology
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| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | Hardy Diagnostics | 11/20/2025SE |
| K251879 | Sulopenem SPM 2 µgJTN · Traditional | Liofilchem | 08/12/2025SE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 06/26/2025SE |
| K250885 | Ceftobiprole BPR 5 µg DiscJTN · Traditional | Liofilchem, Inc. | 06/23/2025SE |
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More from Thermo Fisher Scientific (Oxoid Ltd.)
| 510(k) | Device | Decision |
|---|---|---|
| K070262 | Ertapenem Antimicrobial Susceptibility Test DiscJTN · Traditional | 03/14/2007SE |
| K060286 | Tigecycline Antimicrobial Susceptibility Test DiscJTN · Traditional | 03/17/2006SE |
| K042157 | Daptomycin Antimicrobial Susceptibility Test DiscJTN · Traditional | 09/14/2004SE |
| K011710 | Oxoid PBP2 1 Latex Agglutination TestMYI · Traditional | 04/02/2002SE |
| K012588 | Oxoid Pylori Test Kit, Model DR0130MLYR · Traditional | 12/10/2001SE |
| K010536 | Moxifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 04/24/2001SE |
| K000930 | Gatifloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 05/22/2000SE |
| K000928 | Quinupristin/Dalfopristin Antimicrobial Susceptibility Test DiscJTN · Traditional | 05/15/2000SE |
| K993401 | Dryspot E.Coli 0157 KitGNA · Traditional | 02/28/2000SE |
| K984513 | Trovafloxacin Antimicrobial Susceptibility Test DiscJTN · Traditional | 04/02/1999SE |
Questions and answers
When was Linezolid Antimicrobial Susceptibility Test Disc cleared by the FDA?
Linezolid Antimicrobial Susceptibility Test Disc (K010537) received a 510(k) decision of Substantially Equivalent on April 24, 2001, 60 days after the submission was received.
What is the product code of K010537?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.