In-Vitro Test Determination of Tobramycin
FDA 510(k) K854184 · Clinical Data, Inc.
510(k) numberK854184
Submission
- Device name
- In-Vitro Test Determination of Tobramycin
- Applicant
- Clinical Data, Inc.
Boston, MA, US - Received
- October 15, 1985
- Decision date
- December 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLB – Radioimmunoassay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060853 | Online TDM TobramycinKLB · Traditional | Roche Diagnostics Corp. | 06/09/2006SE |
| K012312 | Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)KLB · Traditional | Diagnostic Products Corp. | 08/20/2001SE |
| K003341 | Emit 2000 Tobramycin Assay Emit 2000 Tobramycin CalibratorsKLB · Traditional | Syva Co., Dade Behring, Inc. | 01/22/2001SE |
| K904304 | Dupont Dimension(R) Tobramllycin(Tobr) MethodKLB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/26/1990SE |
| K903192 | Il Tobramycin AssayKLB · Traditional | Instrumentation Laboratory CO | 08/22/1990SE |
| K893913 | Technicon Ra Systems Tobramycin Test MethodKLB · Traditional | Technicon Instruments Corp. | 08/21/1989SE |
| K882294 | Emit Convenience Pack: Tobramycin AssayKLB · Traditional | Syva Co. | 07/01/1988SE |
| K874223 | Emit Tobramycin AssayKLB · Traditional | Syva Co. | 11/13/1987SE |
| K852671 | Aca Tobramy-Cin Analytical Test PackKLB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/22/1985SE |
| K832763 | Tobramycin ReagentKLB · Traditional | Biosan Laboratories, Inc. | 03/23/1984SE |
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Questions and answers
When was In-Vitro Test Determination of Tobramycin cleared by the FDA?
In-Vitro Test Determination of Tobramycin (K854184) received a 510(k) decision of Substantially Equivalent on December 4, 1985, 50 days after the submission was received.
What is the product code of K854184?
The FDA product code is KLB – Radioimmunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.