FDA.reportPublic FDA data

510(k) K934271

Device
BECKMAN SYNCHRON LACTATE REAGENT
Applicant
BECKMAN-DIAGNOSTIC SYSTEMS GROUP
510(k) number
K934271
Product code
KHP  
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-09
Date received
1993-08-31
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
WILLIAM T RYAN
Address
200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92821 92821

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
K980908LACTATE PRO SYSTEMKdk Corp.1998-09-11
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
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases