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LCY

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
U.V. Spectrometry, Theophylline
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3880
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
GDS ENZYMATIC THEOPHYLLINE REAGENT (K891761)Gds Diagnostics1989-05-16
THEOPHYLLINE ASSAY TO THE GEMSAEC (K780442)Syva Co.1978-04-12
THEOPHYLLINE ASSAY TO THE CENTRIFICHEM (K780441)Syva Co.1978-04-12

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