Biovation Digital Urinometer
FDA 510(k) K790862 · Biovation, Inc.
510(k) numberK790862
Submission
- Device name
- Biovation Digital Urinometer
- Applicant
- Biovation, Inc.
Mchenry, IL, US - Received
- May 7, 1979
- Decision date
- June 28, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRE – Refractometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2800
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954977 | Urine Reagents STRIPS-8 Parameters (Modification)JRE · Traditional | Teco Diagnostics | 03/11/1996SE |
| K941906 | Model 2730 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941903 | Model 2740 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941901 | Model 2721 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941905 | Model 3461 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941904 | Model A300CL Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941902 | Model 3471 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K891681 | Dilectron Urinary Conductivity ProbeJRE · Traditional | Gyrus Medical , Ltd. | 05/01/1990SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | Kyoto Diagnostics, Inc. | 07/16/1984SE |
| K831213 | Specific Gravity InstrumentJRE · Traditional | Iris | 06/30/1983SE |
More from Iris
| 510(k) | Device | Decision |
|---|---|---|
| K925528 | Biovation K-ManagerGKZ · Traditional | 02/05/1993SE |
| K923844 | Lyris 100/120 Laboratory Information SystemJJQ · Traditional | 12/11/1992SE |
| K915071 | Differential Counting BoardGKZ · Traditional | 01/17/1992SE |
| K853026 | Biovation Max Data Management SystemJQP · Traditional | 08/02/1985SE |
| K842401 | Chemistry ConsoleJQP · Traditional | 09/04/1984SE |
| K831830 | Lyris Modular Info SystemJQP · Traditional | 06/25/1984SE |
| K821534 | Hematology Data Management SysJGP · Traditional | 06/10/1982SE |
| K812604 | Biovation Urinalysis ReporterJQP · Traditional | 10/02/1981SE |
| K792045 | Biovation NephelometerJQX · Traditional | 10/30/1979SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | 10/03/1978SE |
Questions and answers
When was Biovation Digital Urinometer cleared by the FDA?
Biovation Digital Urinometer (K790862) received a 510(k) decision of Substantially Equivalent on June 28, 1979, 52 days after the submission was received.
What is the product code of K790862?
The FDA product code is JRE – Refractometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2800.