JME — Radioimmunoassay, Glucagon Class I

FDA Device Classification

FDA product code JME covers "Radioimmunoassay, Glucagon", a Class I medical device regulated under 21 CFR 862.1335. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JME
Device Class
Class I
Regulation Number
862.1335
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K893975diagnostic productsDOUBLE ANTIBODY GLUCAGONOctober 31, 1989
K782143serono laboratoriesRIA KIT, GLUCOSEFebruary 22, 1979
K771948inter science instituteGLUCAGON RIA MODULEJanuary 20, 1978