Product code KHP— Clinical Chemistry

FDA has cleared 27 devices under product code KHP between 1979 and 2013, filed by 22 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20131 clearance
• 20122 clearances
• 20112 clearances
• 20101 clearance
• 20021 clearance
• 20011 clearance
• 19982 clearances
• 19971 clearance
• 19952 clearances
• 19931 clearance
• 19914 clearances
• 19902 clearances
• 19891 clearance
• 19881 clearance
• 19861 clearance

• Yellow Springs Instrument Co., Inc.2 clearances
• Nova Biomedical Corp.2 clearances
• I-Stat Corp.2 clearances
• Eastman Kodak Company2 clearances
• E.I. Dupont DE Nemours & Co., Inc.2 clearances
• Sigma Diagnostics, Inc.1 clearance
• Siemens Healthcare Diagnostics1 clearance
• Roche Medical Electronics, Inc.1 clearance
• Nova Biomedical Corporation1 clearance
• Medical Implements, Inc.1 clearance

• K130113 — PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.·2013-03-11
• K113216 — RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics·2012-05-03
• K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical Corporation·2012-01-05
• K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.·2011-12-20
• K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.·2011-08-17
• K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, Inc.·2010-06-09
• K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEDiametrics Medical, Inc.·2002-01-28
• K011478 — I-STAT SYSTEMI-Stat Corp.·2001-07-02
• K980908 — LACTATE PRO SYSTEMKdk Corp.·1998-09-11
• K982071 — I-STAT LACTATE TESTI-Stat Corp.·1998-06-29
• K971944 — LACTEST IJwt, Inc.·1997-12-17
• K951331 — ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITORBoehringer Mannheim Corp.·1995-08-11
• K936066 — STAT PROFILE PLUS 9 ANALYZERNova Biomedical Corp.·1995-03-09
• K934271 — BECKMAN SYNCHRON LACTATE REAGENTBeckman-Diagnostic Systems Group·1993-11-09
• K914508 — DIMENSION(R) LACTIC ACID METHODE.I. Dupont DE Nemours & Co., Inc.·1991-11-27
• K913197 — KODAK EKTACHEM DT SLIDES (LAC)Eastman Kodak Company·1991-08-26
• K913330 — URINE COLLECTION KIT/DEVICEMedical Implements, Inc.·1991-08-26
• K910534 — SYNCHRON LACTATE REAGENTBeckman Instruments, Inc.·1991-04-08
• K901131 — YSI MODEL 1500 SPORT L-LACTATE ANALYZERYellow Springs Instrument Co., Inc.·1990-08-27
• K897147 — SIGMA PROCEDURE NO. 735Sigma Diagnostics, Inc.·1990-04-03
• K884189 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)Eastman Kodak Company·1989-01-11
• K880787 — EASY-TEST LACTIC ACID (LA)Diagnostic Systems·1988-03-15
• K861741 — TDX REA LACTIC ACIDAbbott Laboratories·1986-07-07
• K852261 — YSI MODEL 2372 TOTAL BLOOD LACTATE KITYellow Springs Instrument Co., Inc.·1985-08-15
• K840778 — LACTATE REAGENTAmerican Dade·1984-04-13
• K802064 — DUPONT ACALACTIC ACID (LA) TESTE.I. Dupont DE Nemours & Co., Inc.·1980-09-26
• K790421 — ROCHE LACTATE ANALYZER 640Roche Medical Electronics, Inc.·1979-05-15