Il Tobramycin Assay
FDA 510(k) K903192 · Instrumentation Laboratory CO
510(k) numberK903192
Submission
- Device name
- Il Tobramycin Assay
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- July 19, 1990
- Decision date
- August 22, 1990
- 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
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| 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 |
| 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 |
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Questions and answers
When was Il Tobramycin Assay cleared by the FDA?
Il Tobramycin Assay (K903192) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 34 days after the submission was received.
What is the product code of K903192?
The FDA product code is KLB – Radioimmunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.