JIH — Flame Photometry, Lithium Class II

FDA Device Classification

Classification Details

Product Code
JIH
Device Class
Class II
Regulation Number
862.3560
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050338akers biosciencesMODIFICATION TO: INSTAREAD LITHIUM SYSTEMMarch 4, 2005
K031579akers laboratoriesINSTAREAD LITHIUM SYSTEMDecember 19, 2003
K011033dade behringDIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132June 7, 2001
K934106eastman kodakKODAK EKTACHEM DTSC II SLIDES (LI)April 25, 1994
K924488eastman kodakKODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)January 26, 1993
K921403ciba corning diagnosticsMODEL 654 ANALYZERJuly 30, 1992
K895465baxter healthcareAMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZEDecember 27, 1989
K894328abbott laboratoriesTDX(R) LITES(TM) LITHIUMNovember 13, 1989
K830636shaban mfgPOTASSIUM DILUENTApril 5, 1983
K800039gilford diagnosticsLITHIUM DILUENT (1500 MM/E)January 21, 1980
K771303corning medical and scientificFLAME PHOTOMETER MODEL 460August 22, 1977
K770824american monitorFLAME PHOTOMETER MOLEL 4600, KDAJuly 15, 1977