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JRE — Refractometer For Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
JRE
Device Class
Class I
Regulation Number
862.2800
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954977teco diagnosticsURINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)March 11, 1996
K941903vee gee scientificMODEL 2740 CLINICAL REFRACTOMETERJanuary 17, 1995
K941901vee gee scientificMODEL 2721 CLINICAL REFRACTOMETERJanuary 17, 1995
K941906vee gee scientificMODEL 2730 CLINICAL REFRACTOMETERJanuary 17, 1995
K941905vee gee scientificMODEL 3461 CLINICAL REFRACTOMETERDecember 13, 1994
K941902vee gee scientificMODEL 3471 CLINICAL REFRACTOMETERDecember 13, 1994
K941904vee gee scientificMODEL A300CL CLINICAL REFRACTOMETERDecember 13, 1994
K891681gyrus medicalDILECTRON URINARY CONDUCTIVITY PROBEMay 1, 1990
K842168kyoto diagnosticsATAGO URINE SPECIFIC GRAVITY & SERUMJuly 16, 1984
K831213irisSPECIFIC GRAVITY INSTRUMENTJune 30, 1983
K811342miles laboratoriesREAGENT STRIPS FOR URINALYSISSeptember 1, 1981
K802959nippon kogakuNIKON URINE REFRACTOMER SG-1December 19, 1980
K790862biovationBIOVATION DIGITAL URINOMETERJune 28, 1979