ClearanceBrief
Panels › Clinical Chemistry › Product code KHP · Class 1

Acid, Lactic, Enzymatic Method

Regulation 862.1450

0510(k)s in 12 months (27 all time)
0recalls in 12 months (19 all time)
12recalls that name a 510(k)
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Top companies in KHP

Decided510(k)Device and applicantCode
Mar 11, 2013K130113PICCOLO LACTATE TEST SYSTEM
Abaxis, Inc.
KHP
May 3, 2012K113216RAPIDPOINT 500 BLOOD GAS ANALYER
Siemens Healthcare Diagnostics
KHP
Jan 5, 2012K112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
Nova Biomedical Corporation
KHP
Dec 20, 2011K112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
Abbott Pont of Care, Inc.
KHP
Aug 17, 2011K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
Nova Biomedical Corp.
KHP
Jun 9, 2010K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
Epocal, Inc., CA
KHP
Jan 28, 2002K013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
Diametrics Medical, Inc.
KHP
Jul 2, 2001K011478I-STAT SYSTEM
I-Stat Corp.
KHP
Sep 11, 1998K980908LACTATE PRO SYSTEM
Kdk Corp., JP
KHP
Jun 29, 1998K982071I-STAT LACTATE TEST
I-Stat Corp.
KHP
Dec 17, 1997K971944LACTEST I
Jwt, Inc.
KHP
Aug 11, 1995K951331ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
Boehringer Mannheim Corp.
KHP
Mar 9, 1995K936066STAT PROFILE PLUS 9 ANALYZER
Nova Biomedical Corp.
KHP
Nov 9, 1993K934271BECKMAN SYNCHRON LACTATE REAGENT
Beckman-Diagnostic Systems Group
KHP
Nov 27, 1991K914508DIMENSION(R) LACTIC ACID METHOD
E.I. Dupont DE Nemours & Co., Inc.
KHP
Aug 26, 1991K913330URINE COLLECTION KIT/DEVICE
Medical Implements, Inc.
KHP
Aug 26, 1991K913197KODAK EKTACHEM DT SLIDES (LAC)
Eastman Kodak Company
KHP
Apr 8, 1991K910534SYNCHRON LACTATE REAGENT
Beckman Instruments, Inc.
KHP
Aug 27, 1990K901131YSI MODEL 1500 SPORT L-LACTATE ANALYZER
Yellow Springs Instrument Co., Inc.
KHP
Apr 3, 1990K897147SIGMA PROCEDURE NO. 735
Sigma Diagnostics, Inc.
KHP
Jan 11, 1989K884189KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
Eastman Kodak Company
KHP
Mar 15, 1988K880787EASY-TEST LACTIC ACID (LA)
Diagnostic Systems
KHP
Jul 7, 1986K861741TDX REA LACTIC ACID
Abbott Laboratories
KHP
Aug 15, 1985K852261YSI MODEL 2372 TOTAL BLOOD LACTATE KIT
Yellow Springs Instrument Co., Inc.
KHP
Apr 13, 1984K840778LACTATE REAGENT
American Dade
KHP
Sep 26, 1980K802064DUPONT ACALACTIC ACID (LA) TEST
E.I. Dupont DE Nemours & Co., Inc.
KHP
May 15, 1979K790421ROCHE LACTATE ANALYZER 640
Roche Medical Electronics, Inc.
KHP

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