Atlas FDA

LCR

17 FDA 510(k) clearances · Product code

36 daysmedian time to decision
101 days90th percentile
17clearances measured

FDA profile

Official device name
Fluorescent Immunoassay, 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
QMS TOBRAMYCIN (K060998)Seradyn, Inc.2006-07-21
ACS TOBRAMYCIN (K974029)Chiron Diagnostics Corp.1998-02-12
TOBRAMYCIN FLEX REAGENT CARTRIDGE (K962818)Dade Intl., Inc.1996-09-13
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (K952568)Beckman Instruments, Inc.1995-08-08
OPUS(R) TOBRAMYCIN (K911940)Pb Diagnostic Systems, Inc.1991-07-01
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (K911613)Exmoor Plastics , Ltd.1991-06-28
INTRAOCULAR PRESSURE REDUCER (K854873)Mira, Inc.1986-02-04
DU PONT TOBRAMYCIN ASSAY REAGENTS (K850058)E.I. Dupont DE Nemours & Co., Inc.1985-01-18
IMMPULSE TOBRAMYCIN ASSAY REAGENTS (K840847)Paragon Diagnostics, Inc.1984-04-04
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (K832408)American Dade1983-08-26
NEEDLE HOLDERS (K822197)Kelleher Corp.1982-08-16
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA (K821542)Electro-Nucleonics Laboratories, Inc.1982-06-03
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY (K820130)Syva Co.1982-02-05
TOBRAMYCIN FLUORESCENT IMMUNOASSAY (K813542)American Diagnostic Corp.1982-01-12
AMES TDA TOBRAMYCIN TEST (K810941)Miles Laboratories, Inc.1981-04-17
CYBREX TOBRAMYCIN (K802668)Abbott Laboratories1980-11-24
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA (K801308)Intl. Diagnostic Technology1980-06-20

Track LCR automatically

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