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JJT — Enzyme Controls (Assayed And Unassayed) Class I

FDA Device Classification

Classification Details

Product Code
JJT
Device Class
Class I
Regulation Number
862.1660
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K090940astoria-pacificSPOTCHECK BLOOD SPOT CONTROL, ASSAYEDDecember 14, 2009
K062751quantimetrixMODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKEROctober 3, 2006
K030768cliniqa corporationCLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELMarch 21, 2003
K030102bayer healthcareADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3January 24, 2003
K021498bio-radLIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELMay 24, 2002
K012656bio-radLIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648September 6, 2001
K993723quantimetrixCARDIASURE CARDIAC MARKERS CONTROLNovember 23, 1999
K993715seracare technologyQUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3November 16, 1999
K992430medical analysis systemsCARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3August 30, 1999
K984437instrumentation laboratoryQUANTEX ASO-CRP-RP CONTROL IIFebruary 2, 1999
K984277medical analysis systemsCARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3December 9, 1998
K982845more diagnosticsCARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, August 21, 1998
K980556bio-radLIQUICHEK CARDIAC MARKERS CONTROL LTFebruary 25, 1998
K974461biosite incorporatedTRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGEDecember 10, 1997
K973974dade intlDADE TRU-LIQUID CARDIAC CONTROLNovember 6, 1997
K972976more diagnosticsCARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELAugust 29, 1997
K972408spectral diagnosticsCARDIAC STATUS CONTROLSJuly 25, 1997
K971777instrumentation laboratoryQUANTEX ASO-CRP-RF CONTROLMay 27, 1997
K970856medical analysis systemsCARDIOISOZYME, CK/LD ISOENZYME CONTROLApril 8, 1997
K965169specialized assaysSTABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)February 6, 1997