Refractometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2800
Recent MDR events
4 adverse event reports on file
- MCKESSON CONSULT 120 URINE ANALYZERSep 10, 2019MalfunctionAcon Laboratories, Inc.2531491-2019-00002
- MCKESSON CONSULT U120Feb 1, 2019InjuryAcon Laboratories, Inc.2531491-2019-00001
- URS - IK URINALYSIS STRIPSFeb 6, 2003InjuryL.w. Scientific, Inc.MW1027455
- CHEMSTRIP 10 UAMay 6, 2002DeathRoche Diagnostics1823260-2002-00133
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
113 firms currently registered for this product code
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Teco Diagnostics
ANAHEIM, CA, US
Btnx Inc.
Pickering Ontario, CA
Healgen Scientific Llc
Houston, TX, US
Arkray, Inc.
Kamigyo-ku Kyoto, JP
Siemens Healthcare Diagnostics Inc
East Walpole, MA, US
Changchun Lyz Technology Co.,ltd
Changchun City Jilin, CN
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Chong Qing Teco Huayi Pharm. Co.
Shapingba Dist., Chongqing, CN
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Stanbio Laboratory
Boerne, TX, US
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Acon Laboratories, Inc.
SAN DIEGO, CA, US
Yd Diagnostics
Yongin-si Gyeonggi, KR
Scientific Supplies & Technology, Inc.
Doral, FL, US
Toptolife Diagnostics Llc
Wilmington, DE, US
Platinum Focus Group Ltd.
London London, City of, GB
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
510(k) clearances
13 clearances for this product code
- Teco DiagnosticsMar 11, 1996
K954977 · URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
- Vee Gee Scientific, Inc.Jan 17, 1995
K941901 · MODEL 2721 CLINICAL REFRACTOMETER
- Vee Gee Scientific, Inc.Jan 17, 1995
K941906 · MODEL 2730 CLINICAL REFRACTOMETER
- Vee Gee Scientific, Inc.Jan 17, 1995
K941903 · MODEL 2740 CLINICAL REFRACTOMETER
- Vee Gee Scientific, Inc.Dec 13, 1994
K941905 · MODEL 3461 CLINICAL REFRACTOMETER
- Vee Gee Scientific, Inc.Dec 13, 1994
K941902 · MODEL 3471 CLINICAL REFRACTOMETER
- Vee Gee Scientific, Inc.Dec 13, 1994
K941904 · MODEL A300CL CLINICAL REFRACTOMETER
- Gyrus Medical , Ltd.May 1, 1990
K891681 · DILECTRON URINARY CONDUCTIVITY PROBE