Product code JRE
- Device name
- Refractometer For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2800
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | Teco Diagnostics | 1996-03-11 |
| K941901 | MODEL 2721 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1995-01-17 |
| K941903 | MODEL 2740 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1995-01-17 |
| K941906 | MODEL 2730 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1995-01-17 |
| K941902 | MODEL 3471 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1994-12-13 |
| K941904 | MODEL A300CL CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1994-12-13 |
| K941905 | MODEL 3461 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | 1994-12-13 |
| K891681 | DILECTRON URINARY CONDUCTIVITY PROBE | Gyrus Medical , Ltd. | 1990-05-01 |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | Kyoto Diagnostics, Inc. | 1984-07-16 |
| K831213 | SPECIFIC GRAVITY INSTRUMENT | Iris | 1983-06-30 |
| K811342 | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1981-09-01 |
| K802959 | NIKON URINE REFRACTOMER SG-1 | Nippon Kogaku, Inc. | 1980-12-19 |
| K790862 | BIOVATION DIGITAL URINOMETER | Biovation, Inc. | 1979-06-28 |
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| 08806141303497 | One+Step 10A | DFI CO.,LTD | 2023-10-16 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 10673486000443 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-01-19 |
| 10673486000429 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-01-19 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 10673486000405 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000399 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000382 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000078 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |