Online TDM Tobramycin
FDA 510(k) K060853 · Roche Diagnostics Corp.
510(k) numberK060853
Submission
- Device name
- Online TDM Tobramycin
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 29, 2006
- Decision date
- June 9, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K854184 | In-Vitro Test Determination of TobramycinKLB · Traditional | Clinical Data, Inc. | 12/04/1985SE |
| 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 |
More from Biosan Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Online TDM Tobramycin cleared by the FDA?
Online TDM Tobramycin (K060853) received a 510(k) decision of Substantially Equivalent on June 9, 2006, 72 days after the submission was received.
What is the product code of K060853?
The FDA product code is KLB – Radioimmunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.