Ceftizoxime 30 MCG Antimicrobial Disk
FDA 510(k) K833709 · General Diagnostics
510(k) numberK833709
Submission
- Device name
- Ceftizoxime 30 MCG Antimicrobial Disk
- Applicant
- General Diagnostics
Mchenry, IL, US - Received
- October 20, 1983
- Decision date
- December 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
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| 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 |
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More from Thermo Fisher Scientific (Oxoid Ltd.)
| 510(k) | Device | Decision |
|---|---|---|
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
| K872882 | Cannabinoid Enzyme Immunoassay KitLDJ · Traditional | 11/03/1987SE |
| K871305 | Cocaine Metabolite Enzyme Immunoassay KitDIO · Traditional | 06/05/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
| K830731 | Netilmicin 30 MCG Antimicrobial DiskJTN · Traditional | 04/08/1983SE |
Questions and answers
When was Ceftizoxime 30 MCG Antimicrobial Disk cleared by the FDA?
Ceftizoxime 30 MCG Antimicrobial Disk (K833709) received a 510(k) decision of Substantially Equivalent on December 30, 1983, 71 days after the submission was received.
What is the product code of K833709?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.