Bio-Monitor Gentamicin
FDA 510(k) K780951 · Monitor Science Corp.
510(k) numberK780951
Submission
- Device name
- Bio-Monitor Gentamicin
- 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
- DKD – Bacillus Subtilis, Microbiological Assay, Gentamicin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K760942 | GentasakDKD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/07/1977SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K790580 | Ria Kit, Prostatic AcidJFH · Traditional | 05/25/1979SE |
| K780950 | Bio-Monitor TobramycinDID · 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 Gentamicin cleared by the FDA?
Bio-Monitor Gentamicin (K780951) 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 K780951?
The FDA product code is DKD – Bacillus Subtilis, Microbiological Assay, Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.