Cefdinir, 5 Ug, Sensi-Disc
FDA 510(k) K981517 · Becton Dickinson Microbiology Systems
510(k) numberK981517
Submission
- Device name
- Cefdinir, 5 Ug, Sensi-Disc
- Applicant
- Becton Dickinson Microbiology Systems
Sparks, MD, US - Received
- April 28, 1998
- Decision date
- June 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K993577 | Cefotaxime/Clavulanic, 30/10UG, BBL Sensi-Disc and Ceftazidime/Clavulanic Acid, 30/10UG…JTN · Traditional | 12/01/1999SE |
| K984631 | Bdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA AssayLSL · Traditional | 11/04/1999SE |
| K980683 | Trovafloxacin 10G, Sensi-DiscJTN · Traditional | 05/01/1998SE |
| K974578 | Grepafloxacin, 5 MG, Sensi-DiscJTN · Traditional | 02/23/1998SE |
| K970333 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | 01/28/1998SE |
| K970512 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | 01/08/1998SE |
| K972758 | Bactec Myco/F-Sputa Culture VialsMDB · Traditional | 08/08/1997SE |
| K972098 | Fosfomycin, 200 MG, Sensi-DiscJTN · Traditional | 07/28/1997SE |
| K970385 | Sparflozacin, 5 MCG, Sensi-DiscJTN · Traditional | 03/10/1997SE |
| K970212 | Levofloxacin, 5MCG, Sensi-DiscJTN · Traditional | 03/06/1997SE |
Questions and answers
When was Cefdinir, 5 Ug, Sensi-Disc cleared by the FDA?
Cefdinir, 5 Ug, Sensi-Disc (K981517) received a 510(k) decision of Substantially Equivalent on June 9, 1998, 42 days after the submission was received.
What is the product code of K981517?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.