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KHP — Acid, Lactic, Enzymatic Method Class I

FDA Device Classification

Classification Details

Product Code
KHP
Device Class
Class I
Regulation Number
862.1450
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130113abaxisPICCOLO LACTATE TEST SYSTEMMarch 11, 2013
K113216siemens healthcare diagnosticsRAPIDPOINT 500 BLOOD GAS ANALYERMay 3, 2012
K112955nova biomedical corporationNOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMJanuary 5, 2012
K112430abbott pont of careI-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEDecember 20, 2011
K100602nova biomedicalNOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSAugust 17, 2011
K093297epocalEPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEJune 9, 2010
K013938diametrics medicalIRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEJanuary 28, 2002
K011478i-statI-STAT SYSTEMJuly 2, 2001
K980908kdkLACTATE PRO SYSTEMSeptember 11, 1998
K982071i-statI-STAT LACTATE TESTJune 29, 1998
K971944jwtLACTEST IDecember 17, 1997
K951331boehringer mannheimACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITORAugust 11, 1995
K936066nova biomedicalSTAT PROFILE PLUS 9 ANALYZERMarch 9, 1995
K934271beckman-diagnostic systems groupBECKMAN SYNCHRON LACTATE REAGENTNovember 9, 1993
K914508e.i. dupont de nemours and coDIMENSION(R) LACTIC ACID METHODNovember 27, 1991
K913330medical implementsURINE COLLECTION KIT/DEVICEAugust 26, 1991
K913197eastman kodakKODAK EKTACHEM DT SLIDES (LAC)August 26, 1991
K910534beckman instrumentsSYNCHRON LACTATE REAGENTApril 8, 1991
K901131yellow springs instrument coYSI MODEL 1500 SPORT L-LACTATE ANALYZERAugust 27, 1990
K897147sigma diagnosticsSIGMA PROCEDURE NO. 735April 3, 1990