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510(k) K980908

Device
LACTATE PRO SYSTEM
Applicant
KDK CORP.
510(k) number
K980908
Product code
KHP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-11
Date received
1998-03-10
Regulation
862.1450
Classification name
Acid, Lactic, Enzymatic Method
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAZUO IKETAKI
Address
57 Nishiaketa-Cho, Higashi-Kujo, Minami-Ku Kyoto JP 601 601

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KHP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.2013-03-11
K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics2012-05-03
K112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical Corporation2012-01-05
K112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.2011-12-20
K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.2011-08-17
K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, Inc.2010-06-09
K013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEDiametrics Medical, Inc.2002-01-28
K011478I-STAT SYSTEMI-Stat Corp.2001-07-02
K982071I-STAT LACTATE TESTI-Stat Corp.1998-06-29
K971944LACTEST IJwt, Inc.1997-12-17
K951331ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITORBoehringer Mannheim Corp.1995-08-11
K936066STAT PROFILE PLUS 9 ANALYZERNova Biomedical Corp.1995-03-09
K934271BECKMAN SYNCHRON LACTATE REAGENTBeckman-Diagnostic Systems Group1993-11-09
K914508DIMENSION(R) LACTIC ACID METHODE.I. Dupont DE Nemours & Co., Inc.1991-11-27
K913197KODAK EKTACHEM DT SLIDES (LAC)Eastman Kodak Company1991-08-26

Legacy Summary#

summary

FDA Review#

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