Tobramycin Ria Kit
FDA 510(k) K800743 · Antibodies, Inc.
510(k) numberK800743
Submission
- Device name
- Tobramycin Ria Kit
- Applicant
- Antibodies, Inc.
Mchenry, IL, US - Received
- April 3, 1980
- Decision date
- April 16, 1980
- 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 |
|---|---|---|
| K890774 | Giardeia(Tm)KHW · Traditional | 04/04/1989SE |
| K843590 | Detect-A-StrepGTZ · Traditional | 10/30/1984SE |
| K822892 | Cortisol Ria KitCGR · Traditional | 11/01/1982SE |
| K812749 | Ultra-DigLCS · Traditional | 10/19/1981SE |
| K812314 | Crithidna Anti-Dna Test KitDHN · Traditional | 09/01/1981SE |
| K802877 | Amikacin Ria KitKLQ · Traditional | 12/19/1980SE |
| K791217 | TSH Ria KitJLW · Traditional | 09/04/1979SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | 11/08/1978SE |
| K781655 | Nephelrate Antiserums 1GACFN · Traditional | 11/08/1978SE |
| K781654 | Nephelrate Antiperums LGMCFN · Traditional | 11/08/1978SE |
Questions and answers
When was Tobramycin Ria Kit cleared by the FDA?
Tobramycin Ria Kit (K800743) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 13 days after the submission was received.
What is the product code of K800743?
The FDA product code is KLB – Radioimmunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.