JMD — Radioimmunoassay, Total Estrogens, Nonpregnancy Class I

FDA Device Classification

FDA product code JMD covers "Radioimmunoassay, Total Estrogens, Nonpregnancy", a Class I medical device regulated under 21 CFR 862.1275. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JMD
Device Class
Class I
Regulation Number
862.1275
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K791651radioassay systems laboratoriesTOTAL ESTROGENS KIT BY RIASeptember 27, 1979
K781009environmental sciences assocANALYZER, SERUM IRON & TOTAL IRON BINDINJuly 27, 1978