METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)

Enzyme Immunoassay, Methadone

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Methadone Metabolite (eddp) Enzime Immunoassay, Cat. No. 190 (500 Test Kit), No. 191 (5000 Test Kit).

Pre-market Notification Details

Device IDK031797
510k NumberK031797
Device Name:METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
ClassificationEnzyme Immunoassay, Methadone
Applicant Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
ContactCheng-i Lin
CorrespondentCheng-i Lin
Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
Product CodeDJR  
CFR Regulation Number862.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-10
Decision Date2003-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B07601980 K031797 000
00811727018083 K031797 000
00811727018090 K031797 000
00811727018106 K031797 000
00811727018113 K031797 000
00811727018120 K031797 000
00811727018151 K031797 000
00811727018168 K031797 000
00811727018175 K031797 000
00811727018182 K031797 000
B07601900 K031797 000
B07601910 K031797 000
B07601920 K031797 000
B07601930 K031797 000
B07601940 K031797 000
B07601950 K031797 000
B07601970 K031797 000
00811727018076 K031797 000

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