Enzyme Immunoassay, Gentamicin

FDA product code LCD · 37 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3450
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-02-05 – 2025-07-09

LCD 2025-07-09

ARCHITECT iGentamicin

Applicant Abbott Laboratories

K number K243500

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LCD 2011-04-01

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS

Applicant Abbott Laboratories

K number K102699

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LCD 2006-06-15

MULTIGENT GENTAMICIN

Applicant Seradyn, Inc.

K number K060709

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LCD 2005-01-06

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042479

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LCD 2002-07-12

ROCHE ONLINE GENTAMICIN

Applicant Roche Diagnostics Corp.

K number K020704

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LCD 2001-09-18

RANDOX GENTAMICIN

Applicant Randox Laboratories, Ltd.

K number K012978

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LCD 2001-08-20

IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)

Applicant Diagnostic Products Corp.

K number K012311

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LCD 2001-04-20

EMIT 2000 GENTAMICIN PLUS ASSAY

Applicant Syva Co., Dade Behring, Inc.

K number K010984

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LCD 1996-09-13

GENTAMICIN FLEX REAGENT CARTRIDGE

Applicant Dade Intl., Inc.

K number K962819

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LCD 1996-09-04

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

Applicant Behring Diagnostics, Inc.

K number K962519

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LCD 1995-08-02

ACS GENTAMICIN

Applicant Ciba Corning Diagnostics Corp.

K number K953020

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LCD 1995-01-25

IL TEST GENTAMICIN CALIBRATORS

Applicant Instrumentation Laboratory CO

K number K943982

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LCD 1994-06-21

AXSYM GENTAMICIN

Applicant Abbott Mfg., Inc.

K number K935376

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LCD 1994-06-02

QMS GENTAMICIN ASSAY

Applicant Seradyn, Inc.

K number K940376

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LCD 1991-09-27

CEDIA(R) GENTAMICIN ASSAY

Applicant Microgenics Corp.

K number K913470

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LCD 1990-10-15

DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K904305

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LCD 1990-09-17

IL GENTAMICIN ASSAY SYSTEM

Applicant Instrumentation Laboratory CO

K number K903743

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LCD 1990-04-12

MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR

Applicant Innotron of Oregon, Inc.

K number K900703

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LCD 1989-10-04

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.

Applicant Baxter Healthcare Corp

K number K895484

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LCD 1989-08-21

TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD

Applicant Technicon Instruments Corp.

K number K893912

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LCD 1987-12-18

EMIT CONVENIENCE PACK: GENTAMICIN ASSAY

Applicant Syva Co.

K number K874703

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LCD 1987-10-29

EMIT QST GENTAMICIN ASSAY

Applicant Syva Co.

K number K873855

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LCD 1987-10-28

EMIT GENTAMICIN ASSAY

Applicant Syva Co.

K number K873854

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LCD 1987-05-12

EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640

Applicant Em Diagnostic Systems, Inc.

K number K871329

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LCD 1986-11-03

EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS

Applicant Syva Co.

K number K862260

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LCD 1986-04-03

TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN

Applicant Technicon Instruments Corp.

K number K860868

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LCD 1986-01-22

DETERMINATION OF GENTAMICIN

Applicant Clinical Data, Inc.

K number K860045

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LCD 1985-08-02

ACA GENTAMICIN TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K852672

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LCD 1985-01-18

DU PONT GENTAMICIN ASSAY REAGENTS

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K850060

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LCD 1983-08-31

STRATUS GENTAMICIN FLUOROMETRIC ENZYM

Applicant American Dade

K number K832445

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LCD 1983-08-08

EMIT AMD GENTAMICIN ASSAY

Applicant Syva Co.

K number K832056

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LCD 1983-06-08

EMIT QST TOBRAMYCIN ASSAY

Applicant Syva Co.

K number K831416

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LCD 1983-06-02

EMIT QST GENTAMICIN ASSAY

Applicant Syva Co.

K number K831304

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LCD 1982-12-22

SOPHEIA GENTAMICIN EIA KIT

Applicant Diagnostic Products Corp.

K number K823387

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LCD 1981-07-15

GENTAMICIN REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K811692

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LCD 1981-07-10

VIRGO IPA FOR DETECTION OF GENTAMICIN

Applicant Electro-Nucleonics Laboratories, Inc.

K number K811744

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LCD 1980-02-05

EMIT TOBRAMYCIN ASSAY

Applicant Syva Co.

K number K800150

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