Tobramycin Reagent
FDA 510(k) K832763 · Biosan Laboratories, Inc.
510(k) numberK832763
Submission
- Device name
- Tobramycin Reagent
- Applicant
- Biosan Laboratories, Inc.
Mchenry, IL, US - Received
- August 16, 1983
- Decision date
- March 23, 1984
- 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 |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860642 | Photron Visual Field AnalyzerHOM · Traditional | 04/15/1986SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | 11/01/1985SE |
| K833193 | Radioimmunoassay, Thyroid Stimu. HormoneJLW · Traditional | 02/04/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | 01/24/1984SE |
| K833318 | Normal Goat SerumDHX · Traditional | 01/03/1984SE |
| K833320 | Amberlite CG50 Resin, 100-200 MeshKEA · Traditional | 12/08/1983SE |
| K833192 | Normal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833191 | Abnormal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | 11/03/1983SE |
Questions and answers
When was Tobramycin Reagent cleared by the FDA?
Tobramycin Reagent (K832763) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 220 days after the submission was received.
What is the product code of K832763?
The FDA product code is KLB – Radioimmunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.