Atlas FDA

JGT

8 FDA 510(k) clearances · Product code

74 daysmedian time to decision
81 days90th percentile
8clearances measured

FDA profile

Official device name
Flame Photometry, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (K896829)Technicon Instruments Corp.1990-02-23
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (K891574)Em Diagnostic Systems, Inc.1989-06-09
COMPONENTS FOR POTASSIUM, SODIUM CHLO (K841610)Shaban Mfg. Co.1984-05-25
SODIUM/POTASSIUM REAGENT SYS (K840216)Sclavo, Inc.1984-03-19
PARALLEL FLAME PHOTOMETER & SODIUM (K834248)American Monitor Corp.1984-01-30
CESIUM DILUENT 7.5M (K811886)Gilford Diagnostics1981-07-23
KLINAR REAGENT PAK, #36010 (K801892)Hi Chem, Inc.1980-10-23
LYTETEK SYSTEM (K770774)Boehringer Mannheim Corp.1977-07-11

Track JGT automatically

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