Tobramycin 125I Ria Kit
FDA 510(k) K780182 · New England Nuclear
510(k) numberK780182
Submission
- Device name
- Tobramycin 125I Ria Kit
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- February 3, 1978
- Decision date
- February 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DID – Bacillus Subtilis Microbiology Assay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820773 | Emit-St Urine Cocaine Metabolite AssayDID · Traditional | Syva Co. | 04/08/1982SE |
| K802038 | Phenytoin Reagent Test KitDID · Traditional | Beckman Instruments, Inc. | 10/23/1980SE |
| K780950 | Bio-Monitor TobramycinDID · Traditional | Monitor Science Corp. | 08/14/1978SE |
| K780048 | Aminoglycoside Test SystemDID · Traditional | Nichols Institute Diagnostics | 01/20/1978SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | 06/14/1984SE |
| K840301 | Rianen Estriol Radioimmunoassay KitCGI · Traditional | 03/30/1984SE |
| K834038 | Rianen Follicle Stimulating HormoneCGJ · Traditional | 01/30/1984SE |
| K833376 | Rianen Luteinizing Hormone Ria KitCEP · Traditional | 12/20/1983SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | 06/08/1983SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | 06/20/1980SE |
| K792175 | Rianen, Vitamin B12 Assay SystemCDD · Traditional | 11/13/1979SE |
| K790817 | Ria Kit, Quantitation of Prostatic AcidJFH · Traditional | 05/07/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | 01/26/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | 01/10/1979SE |
Questions and answers
When was Tobramycin 125I Ria Kit cleared by the FDA?
Tobramycin 125I Ria Kit (K780182) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 10 days after the submission was received.
What is the product code of K780182?
The FDA product code is DID – Bacillus Subtilis Microbiology Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.