CDR — 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine Class I

FDA Device Classification

FDA product code CDR covers "1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine", a Class I medical device regulated under 21 CFR 862.1730. 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
CDR
Device Class
Class I
Regulation Number
862.1730
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K970093astoria-pacificTYROSINE 50-HOUR REAGENT KITMarch 19, 1998