Atlas FDA

ONLINE TDM TOBRAMYCIN

FDA 510(k) clearance K060853 · decided 2006-06-09

Clearance details

K-number
K060853
Device name
ONLINE TDM TOBRAMYCIN
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2006-03-29
Decision date
2006-06-09
Days to decision
72 days
Clearance type
Traditional
Product code
KLB
Device class
2
Regulation number
862.3900
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) (K012312)Diagnostic Products Corp.2001-08-20
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (K003341)Syva Co., Dade Behring, Inc.2001-01-22
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD (K904304)E.I. Dupont DE Nemours & Co., Inc.1990-10-26
IL TOBRAMYCIN ASSAY (K903192)Instrumentation Laboratory CO1990-08-22
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD (K893913)Technicon Instruments Corp.1989-08-21
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (K882294)Syva Co.1988-07-01
EMIT TOBRAMYCIN ASSAY (K874223)Syva Co.1987-11-13
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (K854184)Clinical Data, Inc.1985-12-04
ACA TOBRAMY-CIN ANALYTICAL TEST PACK (K852671)E.I. Dupont DE Nemours & Co., Inc.1985-07-22
TOBRAMYCIN REAGENT (K832763)Biosan Laboratories, Inc.1984-03-23
TOBRAMYCIN ANALYTICAL TEST PACK-ACA (K832985)E.I. Dupont DE Nemours & Co., Inc.1983-10-27
COAT-A-COUNT TOBRAMYCIN RIA KIT (K822858)Diagnostic Products Corp.1982-10-18

Recalls involving this device

RecordFirmDate
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P recall (Z-0917-2007)Roche Diagnostics Corp.2007-06-09
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog recall (Z-0918-2007)Roche Diagnostics Corp.2007-06-09

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