JRI — Cuvette, Thermostated Class I

FDA Device Classification

FDA product code JRI covers "Cuvette, Thermostated", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JRI
Device Class
Class I
Regulation Number
862.2050
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K873656medatronMEDATRON CUVETTE DISCDecember 14, 1987
K780888gilford instrument laboratoriesTHERMO SET ELECTRONIC TEM. CONTROLLERJune 28, 1978
K760769perkin-elmerTEMPERATURE REGULATED FIVE CELL HOLDERSNovember 30, 1976
K760197coulter electronicsACCUVETTE IIJuly 19, 1976