Atlas FDA

CDA

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device class
Class I (low risk)
Regulation
21 CFR 862.1390
Medical specialty
Clinical Chemistry
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RecordFirmDate
BIO-RAD URINARY 5-HIAA BY HPLC (K952817)Bio-Rad1995-08-01
SEROTONIN ENZYME IMMUNOASSAY (K903609)Immunotech Corp.1990-10-22
TDXR 5-HIAA (URINE) (K854946)Abbott Laboratories1986-01-17

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Every clearance here is in the API, with alerts when new ones post.