GDS ENZYMATIC THEOPHYLLINE REAGENT

U.v. Spectrometry, Theophylline

GDS DIAGNOSTICS

The following data is part of a premarket notification filed by Gds Diagnostics with the FDA for Gds Enzymatic Theophylline Reagent.

Pre-market Notification Details

Device IDK891761
510k NumberK891761
Device Name:GDS ENZYMATIC THEOPHYLLINE REAGENT
ClassificationU.v. Spectrometry, Theophylline
Applicant GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart,  IN  46515
ContactDe Castro
CorrespondentDe Castro
GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart,  IN  46515
Product CodeLCY  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-24
Decision Date1989-05-16

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