JKB — Radioimmunoassay, Compound S (11-Deoxycortisol) Class I

FDA Device Classification

FDA product code JKB covers "Radioimmunoassay, Compound S (11-Deoxycortisol)", a Class I medical device regulated under 21 CFR 862.1185. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
JKB
Device Class
Class I
Regulation Number
862.1185
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K791740radioassay systems laboratoriesSERUM 11-DESOXYCORTISOL I AS TRACERSeptember 27, 1979