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JFM — Enzymatic Method, Bilirubin Class II

FDA Device Classification

Classification Details

Product Code
JFM
Device Class
Class II
Regulation Number
862.1110
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K170065siemens healthcare diagnosticsADVIA® Chemistry Total Bilirubin_2 (TBIL_2)March 9, 2017
K152343randox laboratories limitedDirect BilirubinFebruary 16, 2016
K152344randox laboratories limitedTotal BilirubinJanuary 28, 2016
K063845bayer healthcareADVIA CHEMISTRY TOTAL BILIRUBIN_2December 7, 2007
K053131wako chemicals usaWAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191December 30, 2005
K053132wako chemicals usaWAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791December 30, 2005
K053090beckman coulterDRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATORDecember 16, 2005
K050266stanbio laboratoryDIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORJune 30, 2005
K970985wako chemicals usaWAKO TOTAL BILIRUBIN VApril 21, 1997
K904660diagnostic chemicals, ltd. (usa)ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14November 20, 1990
K843174beckman instrumentsDRI-STAT ENZYMATIC BILIRUBIN TEST KITSeptember 14, 1984