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JJB — Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Class I

FDA Device Classification

Classification Details

Product Code
JJB
Device Class
Class I
Regulation Number
862.1115
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K943436teco diagnosticsURINE REAGENT STRIPS-8 PARAMETERSApril 24, 1995
K943008genesis labsBIOSCAN REAGENT STRIPSAugust 8, 1994
K873553wako chemicals usaWAKO(TM) PRETEST 8ASeptember 22, 1987
K862806amatech internationalURINE DIAGNOSTIC REAGENT STRIPSDecember 4, 1986
K833521syn-kitREAGENT TESTS STRIP COMBINATIONSJanuary 11, 1984