Atlas FDA

LCD

37 FDA 510(k) clearances · Product code

39 daysmedian time to decision
193 days90th percentile
37clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Gentamicin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3450
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 3 · 2010: 4 · 2012: 19 · 2013: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ARCHITECT iGentamicin (K243500)Abbott Laboratories2025-07-09
ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699)Abbott Laboratories2011-04-01
MULTIGENT GENTAMICIN (K060709)Seradyn, Inc.2006-06-15
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479)Ortho-Clinical Diagnostics, Inc.2005-01-06
ROCHE ONLINE GENTAMICIN (K020704)Roche Diagnostics Corp.2002-07-12
RANDOX GENTAMICIN (K012978)Randox Laboratories, Ltd.2001-09-18
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (K012311)Diagnostic Products Corp.2001-08-20
EMIT 2000 GENTAMICIN PLUS ASSAY (K010984)Syva Co., Dade Behring, Inc.2001-04-20
GENTAMICIN FLEX REAGENT CARTRIDGE (K962819)Dade Intl., Inc.1996-09-13
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519)Behring Diagnostics, Inc.1996-09-04
ACS GENTAMICIN (K953020)Ciba Corning Diagnostics Corp.1995-08-02
IL TEST GENTAMICIN CALIBRATORS (K943982)Instrumentation Laboratory CO1995-01-25
AXSYM GENTAMICIN (K935376)Abbott Mfg., Inc.1994-06-21
QMS GENTAMICIN ASSAY (K940376)Seradyn, Inc.1994-06-02
CEDIA(R) GENTAMICIN ASSAY (K913470)Microgenics Corp.1991-09-27
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD (K904305)E.I. Dupont DE Nemours & Co., Inc.1990-10-15
IL GENTAMICIN ASSAY SYSTEM (K903743)Instrumentation Laboratory CO1990-09-17
MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (K900703)Innotron of Oregon, Inc.1990-04-12
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. (K895484)Baxter Healthcare Corp1989-10-04
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD (K893912)Technicon Instruments Corp.1989-08-21
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY (K874703)Syva Co.1987-12-18
EMIT QST GENTAMICIN ASSAY (K873855)Syva Co.1987-10-29
EMIT GENTAMICIN ASSAY (K873854)Syva Co.1987-10-28
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 (K871329)Em Diagnostic Systems, Inc.1987-05-12
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS (K862260)Syva Co.1986-11-03
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN (K860868)Technicon Instruments Corp.1986-04-03
DETERMINATION OF GENTAMICIN (K860045)Clinical Data, Inc.1986-01-22
ACA GENTAMICIN TEST PACK (K852672)E.I. Dupont DE Nemours & Co., Inc.1985-08-02
DU PONT GENTAMICIN ASSAY REAGENTS (K850060)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
STRATUS GENTAMICIN FLUOROMETRIC ENZYM (K832445)American Dade1983-08-31
EMIT AMD GENTAMICIN ASSAY (K832056)Syva Co.1983-08-08
EMIT QST TOBRAMYCIN ASSAY (K831416)Syva Co.1983-06-08
EMIT QST GENTAMICIN ASSAY (K831304)Syva Co.1983-06-02
SOPHEIA GENTAMICIN EIA KIT (K823387)Diagnostic Products Corp.1982-12-22
GENTAMICIN REAGENT TEST KIT (K811692)Beckman Instruments, Inc.1981-07-15
VIRGO IPA FOR DETECTION OF GENTAMICIN (K811744)Electro-Nucleonics Laboratories, Inc.1981-07-10
EMIT TOBRAMYCIN ASSAY (K800150)Syva Co.1980-02-05

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Every clearance here is in the API, with alerts when new ones post.