Kanamycin Ria
FDA 510(k) K772038 · Monitor Science Corp.
510(k) numberK772038
Submission
- Device name
- Kanamycin Ria
- Applicant
- Monitor Science Corp.
Mchenry, IL, US - Received
- October 28, 1977
- Decision date
- January 12, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KJI – Radioimmunoassay, Kanamycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3520
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832769 | Ames Tda Kanamycin Test-Control SerumKJI · Traditional | Miles Laboratories, Inc. | 09/29/1983SE |
| K823370 | Advance TM Emit(R) & TM Amikacin AssayKJI · Traditional | Syva Co. | 12/03/1982SE |
| K823062 | Kenamycin Fluorescent Immunoassay FiaKJI · Traditional | American Diagnostic Corp. | 11/10/1982SE |
| K822808 | TDX KenamycinKJI · Traditional | Abbott Laboratories | 10/08/1982SE |
| K782125 | Ria Kit, KanamycinKJI · Traditional | Diagnostic Products Corp. | 01/10/1979SE |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K790580 | Ria Kit, Prostatic AcidJFH · Traditional | 05/25/1979SE |
| K780951 | Bio-Monitor GentamicinDKD · Traditional | 08/14/1978SE |
| K780950 | Bio-Monitor TobramycinDID · Traditional | 08/14/1978SE |
| K780949 | Bio-Monitor AmikacinKLP · Traditional | 08/14/1978SE |
| K772039 | Beta-Hcg RiaJHI · Traditional | 11/23/1977SE |
Questions and answers
When was Kanamycin Ria cleared by the FDA?
Kanamycin Ria (K772038) received a 510(k) decision of Substantially Equivalent on January 12, 1978, 76 days after the submission was received.
What is the product code of K772038?
The FDA product code is KJI – Radioimmunoassay, Kanamycin, a Class II (moderate risk) device regulated under 21 CFR 862.3520.