Gentamicin Disk (120MCG)
FDA 510(k) K961818 · Remel, L.P.
510(k) numberK961818
Submission
- Device name
- Gentamicin Disk (120MCG)
- Applicant
- Remel, L.P.
Lenexa, KS, US - Received
- May 10, 1996
- Decision date
- July 10, 1996
- 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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|---|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | Hardy Diagnostics | 08/20/2026SE |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
| K261853 | Gepotidacin GEP 10 µgJTN · Traditional | Liofilchem, Inc. | 07/23/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 05/11/2026SE |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 12/05/2025SE |
| 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 |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 06/12/2025SE |
More from Thermo Fisher Scientific (Oxoid Ltd.)
| 510(k) | Device | Decision |
|---|---|---|
| K972359 | Remel Bile Esculin Azide Agar W/6 Mcg/Ml VancomycinJSO · Traditional | 08/28/1997SE |
| K964315 | Remel Staph Latex KitJWX · Traditional | 02/07/1997SE |
| K964421 | Remel Meropenem 10UG Susceptibility DiskJTN · Traditional | 12/06/1996SE |
| K961046 | 10B Arginine BrothJSM · Traditional | 09/18/1996SE |
| K955143 | RPR Liquid ControlsGMP · Traditional | 07/30/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | 07/29/1996SE |
| K961819 | Streptomycin Disk (300MCG)JTN · Traditional | 07/10/1996SE |
| K960313 | Mueller Hinton Agar with 2% NaciJTZ · Traditional | 03/25/1996SE |
| K954986 | GC Base W/ 1% GchiJTY · Traditional | 02/16/1996SE |
Questions and answers
When was Gentamicin Disk (120MCG) cleared by the FDA?
Gentamicin Disk (120MCG) (K961818) received a 510(k) decision of Substantially Equivalent on July 10, 1996, 61 days after the submission was received.
What is the product code of K961818?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.