Bio-Monitor Tobramycin
FDA 510(k) K780950 · Monitor Science Corp.
510(k) numberK780950
Submission
- Device name
- Bio-Monitor Tobramycin
- Applicant
- Monitor Science Corp.
Mchenry, IL, US - Received
- June 9, 1978
- Decision date
- August 14, 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 |
| K780182 | Tobramycin 125I Ria KitDID · Traditional | New England Nuclear | 02/13/1978SE |
| K780048 | Aminoglycoside Test SystemDID · Traditional | Nichols Institute Diagnostics | 01/20/1978SE |
More from Nichols Institute Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K790580 | Ria Kit, Prostatic AcidJFH · Traditional | 05/25/1979SE |
| K780951 | Bio-Monitor GentamicinDKD · Traditional | 08/14/1978SE |
| K780949 | Bio-Monitor AmikacinKLP · Traditional | 08/14/1978SE |
| K772038 | Kanamycin RiaKJI · Traditional | 01/12/1978SE |
| K772039 | Beta-Hcg RiaJHI · Traditional | 11/23/1977SE |
Questions and answers
When was Bio-Monitor Tobramycin cleared by the FDA?
Bio-Monitor Tobramycin (K780950) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 66 days after the submission was received.
What is the product code of K780950?
The FDA product code is DID – Bacillus Subtilis Microbiology Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.