Atlas FDA

KLB

23 FDA 510(k) clearances · Product code

29 daysmedian time to decision
83 days90th percentile
23clearances measured

FDA profile

Official device name
Radioimmunoassay, Tobramycin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3900
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
ONLINE TDM TOBRAMYCIN (K060853)Roche Diagnostics Corp.2006-06-09
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
MRI TOBRAMYCIN RIA KIT (K813516)Microanalytic Research, Inc.1981-12-29
KALLESTAD ANTISERA TO TOBRAMYCIN (K812415)Kallestad Laboratories, Inc.1981-09-09
MACRO-VUE CARD TEST (K810597)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-03-17
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT (K810011)Alpha Gamma Laboratory1981-01-28
TOBRAMYCIN RIA KIT (K800743)Antibodies, Inc.1980-04-16
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY (K791596)Bio-Rad1979-10-17
QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO (K791502)Bio-Rad1979-09-04
AMES TDA/TOBRAMYCIN (K791435)Miles Laboratories, Inc.1979-08-16
IN VITRO TOBRAMYCIN RIA KIT (K780934)Clinical Assays, Inc.1978-08-14
TOBRAMYCIN RIA KIT (K760967)Diagnostic Products Corp.1976-12-22

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