510(k) K941904
- Device
- MODEL A300CL CLINICAL REFRACTOMETER
- Applicant
- VEE GEE SCIENTIFIC, INC.
- 510(k) number
- K941904
- Product code
- JRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-12-13
- Date received
- 1994-04-19
- Regulation
- 862.2800
- Classification name
- Refractometer For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE LYTLE
- Address
- 13600 NE 126th Pl., Suite A Kirkland WA US 98034 98034
FDA Registration Numbers#
- 9611444
- 3006198300
- 3005527296
- 3005360469
- 9610633
- 3003795116
- 9710094
- 1181121
- 4580
- 1836161
- 1319721
- 3004043187
- 9680746
- 3007301207
- 3003741796
- 3010324880
- 3031915160
- 2432235
- 1832216
- 2244821
- 1649661
- 8040374
- 3006621318
- 1036362
- 8030433
- 3030446844
- 2122870
- 3021186226
- 1417592
- 3042471840
- 3002637618
- 1061932
- 9615507
- 3016712364
- 3018126397
- 3008517993
- 1832816
- 3009238284
- 3010891909
- 3024171133
- 8030607
- 2531491
- 3003422726
- 3003917514
- 1616487
- 3008058135
- 9610126
- 2029372
- 3012494290
- 2030633
- 3012421607
- 3009448641
- 1924066
- 9615162
- 3004192065
Source Documents#
Other 510(k) Records For Product Code JRE #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases