URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS

Blood, Occult, Colorimetric, In Urine

DIRUI INDUSTRIAL CO., LTD.

The following data is part of a premarket notification filed by Dirui Industrial Co., Ltd. with the FDA for Uristik H Series Reagent Strips For Urinalysis.

Pre-market Notification Details

Device IDK040703
510k NumberK040703
Device Name:URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
ClassificationBlood, Occult, Colorimetric, In Urine
Applicant DIRUI INDUSTRIAL CO., LTD. 7560 LINDBERGH DRIVE Gaithersburg,  MD  20879
ContactJoseph F Ludford
CorrespondentJoseph F Ludford
DIRUI INDUSTRIAL CO., LTD. 7560 LINDBERGH DRIVE Gaithersburg,  MD  20879
Product CodeJIO  
Subsequent Product CodeCDM
Subsequent Product CodeCEN
Subsequent Product CodeJIL
Subsequent Product CodeJIN
Subsequent Product CodeJIR
Subsequent Product CodeJJQ
Subsequent Product CodeJMA
Subsequent Product CodeJMT
Subsequent Product CodeJRE
Subsequent Product CodeKQO
Subsequent Product CodeLJX
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-17
Decision Date2004-08-26
Summary:summary

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