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510(k) K850060

Device
DU PONT GENTAMICIN ASSAY REAGENTS
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K850060
Product code
LCD  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-18
Date received
1985-01-08
Regulation
862.3450
Classification name
Enzyme Immunoassay, Gentamicin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROGER C BRIDEN
Address
Medical Products Dept. Barley Mill Plz., P22-1170 Wilmington DE US 19898 19898

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243500ARCHITECT iGentamicinAbbott Laboratories2025-07-09
K102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott Laboratories2011-04-01
K060709MULTIGENT GENTAMICINSeradyn, Inc.2006-06-15
K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.2005-01-06
K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.2002-07-12
K012978RANDOX GENTAMICINRandox Laboratories, Ltd.2001-09-18
K012311IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)Diagnostic Products Corp.2001-08-20
K010984EMIT 2000 GENTAMICIN PLUS ASSAYSyva Co., Dade Behring, Inc.2001-04-20
K962819GENTAMICIN FLEX REAGENT CARTRIDGEDade Intl., Inc.1996-09-13
K962519EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORSBehring Diagnostics, Inc.1996-09-04
K953020ACS GENTAMICINCiba Corning Diagnostics Corp.1995-08-02
K943982IL TEST GENTAMICIN CALIBRATORSInstrumentation Laboratory CO1995-01-25
K935376AXSYM GENTAMICINAbbott Mfg., Inc.1994-06-21
K940376QMS GENTAMICIN ASSAYSeradyn, Inc.1994-06-02
K913470CEDIA(R) GENTAMICIN ASSAYMicrogenics Corp.1991-09-27

Legacy Summary#

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FDA Review#

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