FDA.report

510(k) K943982

Device
Il Test Gentamicin Calibrators
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K943982
Product code
LCD
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-25
Date received
1994-06-07
Regulation
862.3450
Classification name
Enzyme Immunoassay, Gentamicin
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
WALLIS W CADY
Address
101 Hartwell Ave. Lexington MA US 02421 02421

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K243500ARCHITECT iGentamicinAbbott Laboratories2025-07-09
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K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.2005-01-06
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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
K935376AXSYM GENTAMICINAbbott Mfg., Inc.1994-06-21
K940376QMS GENTAMICIN ASSAYSeradyn, Inc.1994-06-02
K913470CEDIA(R) GENTAMICIN ASSAYMicrogenics Corp.1991-09-27
K904305DUPONT DIMENSION(R) GENTAMICIN(GENT) METHODE.I. Dupont DE Nemours & Co., Inc.1990-10-15