JMA — Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Class I

FDA Device Classification

FDA product code JMA covers "Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)", a Class I medical device regulated under 21 CFR 862.1095. 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
JMA
Device Class
Class I
Regulation Number
862.1095
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K931523quantimetrixQUANTIMETRIX C-CLEAR(TM)June 25, 1993
K830978helena laboratoriesHELENA BIOSTRIP AMay 13, 1983
K822709laprol scientificURITEST 9, INLAB REAGENT STRIPS URINALYJanuary 28, 1983