General Diagnostics Ceftazidime 30 MCG Susc Disk
FDA 510(k) K852689 · Warner-Lambert Co.
510(k) numberK852689
Submission
- Device name
- General Diagnostics Ceftazidime 30 MCG Susc Disk
- Applicant
- Warner-Lambert Co.
Morris Plains, NJ, US - Received
- June 25, 1985
- Decision date
- August 19, 1985
- 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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| 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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| K024160 | Neosporin Scar SolutionMDA · Traditional | 03/17/2003SE |
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| K861510 | Multilumen Viapic Central Line CatheterFOZ · Traditional | 06/09/1986SE |
| K852967 | General Diagnostics' Ceftriaxone 30MCG Susdep DiskJTN · Traditional | 08/19/1985SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | 08/13/1985SE |
| K852889 | General Diagnostics Rapid E. Coli TestJTO · Traditional | 07/23/1985SE |
| K850486 | General Diag. Chromostrate Heparin AssayKFF · Traditional | 05/08/1985SE |
| K850412 | Gen. Diag. Chromostrate Antithrombin III AssayJBQ · Traditional | 05/08/1985SE |
| K850411 | Gen. Diag. Chromostrate ALPHA-2 Antiplasmin AssayLGP · Traditional | 05/08/1985SE |
Questions and answers
When was General Diagnostics Ceftazidime 30 MCG Susc Disk cleared by the FDA?
General Diagnostics Ceftazidime 30 MCG Susc Disk (K852689) received a 510(k) decision of Substantially Equivalent on August 19, 1985, 55 days after the submission was received.
What is the product code of K852689?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.