Atago Urine Specific Gravity & Serum
FDA 510(k) K842168 · Kyoto Diagnostics, Inc.
510(k) numberK842168
Submission
- Device name
- Atago Urine Specific Gravity & Serum
- Applicant
- Kyoto Diagnostics, Inc.
Mchenry, IL, US - Received
- May 31, 1984
- Decision date
- July 16, 1984
- 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 |
| K831213 | Specific Gravity InstrumentJRE · Traditional | Iris | 06/30/1983SE |
| K811342 | Reagent Strips for UrinalysisJRE · Traditional | Miles Laboratories, Inc. | 09/01/1981SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861733 | Additional Kyotest Urine Test Reagent StripsJIL · Traditional | 07/25/1986SE |
| K843003 | Glucose Auto& Stat GA-1120CGA · Traditional | 09/28/1984SE |
| K842750 | Osmotic Pressure Auto & Stat OM-6010JJM · Traditional | 08/17/1984SE |
| K841715 | Kyotest UK Urine Test Reagent StripJIN · Traditional | 05/31/1984SE |
| K841714 | Kyotest 2V, Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K841713 | Kyotest Ug Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K840828 | Kyotest 8VJMT · Traditional | 05/14/1984SE |
| K840827 | Kyotest 5VCEN · Traditional | 05/14/1984SE |
| K840996 | Urine Analyzer SystemKQO · Traditional | 05/01/1984SE |
| K840829 | Kyotest UgkJIL · Traditional | 04/19/1984SE |
Questions and answers
When was Atago Urine Specific Gravity & Serum cleared by the FDA?
Atago Urine Specific Gravity & Serum (K842168) received a 510(k) decision of Substantially Equivalent on July 16, 1984, 46 days after the submission was received.
What is the product code of K842168?
The FDA product code is JRE – Refractometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2800.