CDA — Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin Class I

FDA Device Classification

FDA product code CDA covers "Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin", a Class I medical device regulated under 21 CFR 862.1390. 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
CDA
Device Class
Class I
Regulation Number
862.1390
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K952817Bio-RadBIO-RAD URINARY 5-HIAA BY HPLCAug 1, 1995
K903609ImmunotechSEROTONIN ENZYME IMMUNOASSAYOct 22, 1990
K854946Abbott LaboratoriesTDXR 5-HIAA (URINE)Jan 17, 1986