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JJF — Analyzer, Chemistry, Micro, For Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
JJF
Device Class
Class I
Regulation Number
862.2170
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052794diasorinETI-MAX 3000March 31, 2006
K040332arkrayPOLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERJune 16, 2004
K033734roche diagnosticsLIGHTCYCLER INSTRUMENT VERSION 1.2December 17, 2003
K013654precision systemsPRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERJune 5, 2002
K012966roche molecular systemsROCHE COBAS TAQMAN ANALYZERFebruary 1, 2002
K993634caresideCARESIDE ANALYZERDecember 2, 1999
K973628vital scientific n.vVITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAMarch 13, 1998
K980056exigent diagnosticsCARESIDE ANALYZERMarch 6, 1998
K973177diamedixMAGO AUTOMATED EIA PROCESSOROctober 9, 1997
K971491synermedSYNERMED IR 200 CHEMISTRY ANALYZERJune 26, 1997
K964506roche molecular systemsROCHE COBAS AMPLICOR ANALYZERMay 21, 1997
K965103diagnostic productsWINMAX SOFTWARE SYSTEMSMay 9, 1997
K964409hcl laboratory systemsHCL - 200 BIOCHEMISTRY ANALYZERJanuary 22, 1997
K961209seacBRIO AUTOMATIC SAMPLINC UNITDecember 24, 1996
K943978waters chromatography divisionWATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSISMay 2, 1995
K942676beckman-diagnostic systems groupSYNCHRON CX3 DELTANovember 2, 1994
K925093beckman instrumentsSYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANANovember 16, 1993
K912055syvaSYVA EDMSJune 10, 1991
K903357syvaSYVA(R) ETS(R) PLUS SYSTEMSeptember 27, 1990
K893768olympusMODIFIED PK300 AUTOMATIC EIA ANALYZERAugust 15, 1989