JMX — Ninhydrin, Nitrogen (Amino-Nitrogen) Class I

FDA Device Classification

FDA product code JMX covers "Ninhydrin, Nitrogen (Amino-Nitrogen)", a Class I medical device regulated under 21 CFR 862.1515. 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
JMX
Device Class
Class I
Regulation Number
862.1515
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K863188biotecx laboratoriesHPL RIA KITSeptember 25, 1986
K780847beckman instrumentsNINHYDRIN REAGENT KITJune 13, 1978