Atlas FDA

ROCHE ONLINE GENTAMICIN

FDA 510(k) clearance K020704 · decided 2002-07-12

Clearance details

K-number
K020704
Device name
ROCHE ONLINE GENTAMICIN
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2002-03-04
Decision date
2002-07-12
Days to decision
130 days
Clearance type
Traditional
Product code
LCD
Device class
2
Regulation number
862.3450
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
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

Recalls involving this device

RecordFirmDate
Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modu recall (Z-0970-2010)Roche Diagnostics Operations, Inc.2010-03-08
Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Cat recall (Z-0971-2010)Roche Diagnostics Operations, Inc.2010-03-08
Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog recall (Z-0972-2010)Roche Diagnostics Operations, Inc.2010-03-08

PMA approvals by this applicant

RecordFirmDate
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22