Model 2740 Clinical Refractometer
FDA 510(k) K941903 · Vee Gee Scientific, Inc.
510(k) numberK941903
Submission
- Device name
- Model 2740 Clinical Refractometer
- Applicant
- Vee Gee Scientific, Inc.
Kirkland, WA, US - Received
- April 19, 1994
- Decision date
- January 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K811342 | Reagent Strips for UrinalysisJRE · Traditional | Miles Laboratories, Inc. | 09/01/1981SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941906 | Model 2730 Clinical RefractometerJRE · Traditional | 01/17/1995SE |
| K941901 | Model 2721 Clinical RefractometerJRE · Traditional | 01/17/1995SE |
| K941905 | Model 3461 Clinical RefractometerJRE · Traditional | 12/13/1994SE |
| K941904 | Model A300CL Clinical RefractometerJRE · Traditional | 12/13/1994SE |
| K941902 | Model 3471 Clinical RefractometerJRE · Traditional | 12/13/1994SE |
Questions and answers
When was Model 2740 Clinical Refractometer cleared by the FDA?
Model 2740 Clinical Refractometer (K941903) received a 510(k) decision of Substantially Equivalent on January 17, 1995, 273 days after the submission was received.
What is the product code of K941903?
The FDA product code is JRE – Refractometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2800.