Home / Device Classification / CDH

CDH — Acid, Uric, Phosphotungstate Reduction Class I

FDA Device Classification

Classification Details

Product Code
CDH
Device Class
Class I
Regulation Number
862.1775
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K850933dilabURIC ACIDJune 25, 1985
K841067medical specialtiesURIC ACID REAGENT SETMay 1, 1984
K821213omega medical electronicsURIC ACID REAGENT SETJuly 13, 1982
K813076american monitorPHOSPHOTUNGSTATE REDUCTION, URIC ACIDNovember 16, 1981
K810088bio-analytics laboratoriesURIC ACID (TPTZ) COLORINMETRICJanuary 28, 1981
K800672diagnostic solutionsSMAC REPLACEMENT REAGENTS/DETERM-URIC-ACMay 28, 1980
K800190stanbio laboratorySTANBIO DIRECT URIC ACID TEST SET #0770February 13, 1980
K792403volu sol medical industriesELVI URIC ACID-COLORIMETRIC METHODDecember 7, 1979
K792412volu sol medical industriesELVI URIC ACIDDecember 7, 1979
K790019fisher scientific coSERUM, URIC ACID DETERMINATIONFebruary 26, 1979
K772082bd becton dickinson vacutainer systems preanalyticENZAC URIC ACID 100-TEST KITNovember 28, 1977
K771842gamma enterprisesURIC ACIDOctober 25, 1977
K770564mallinckrodt critical careURIC ACID TEST KITJune 3, 1977
K770459icn pharmaceuticalsURIC ACID PROCEDURE, TEKPOINT DIRECTApril 29, 1977
K760477simmler and sonREAGENTS-4 FOR URIC ACID DETERMINATIONOctober 29, 1976