Uri-Val
FDA 510(k) K843680 · Cenogenics Corp.
510(k) numberK843680
Submission
- Device name
- Uri-Val
- Applicant
- Cenogenics Corp.
Morganville, NJ, US - Received
- September 18, 1984
- Decision date
- March 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMZ – Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1540
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K844589 | Osmolarity StandardsJMZ · Traditional | Rna Medical Corp. | 03/01/1985SE |
More from Rna Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K042641 | CHEMVIEW-10JIL · Traditional | 01/07/2005SE |
| K030533 | Accunate One-Step,Accunate One-Step Cassette, Accunate-Choice, Accunate Home Pregnancy…LCX · Traditional | 04/17/2003SE |
| K992397 | Accunate-One Step, Accunate-One Step CassetteJHI · Traditional | 08/26/1999SE |
| K894793 | MonodexKTN · Traditional | 08/21/1989SE |
Questions and answers
When was Uri-Val cleared by the FDA?
Uri-Val (K843680) received a 510(k) decision of Substantially Equivalent on March 29, 1985, 192 days after the submission was received.
What is the product code of K843680?
The FDA product code is JMZ – Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality, a Class I (low risk) device regulated under 21 CFR 862.1540.