LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS

Enzyme Immunoassay, Opiates

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls.

Pre-market Notification Details

Device IDK120763
510k NumberK120763
Device Name:LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
ClassificationEnzyme Immunoassay, Opiates
Applicant Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale,  CA  94085
ContactBernice Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale,  CA  94085
Product CodeDJG  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-13
Decision Date2012-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B0760252B0 K120763 000
00811727017536 K120763 000
00811727017529 K120763 000
00811727017512 K120763 000
00811727017505 K120763 000
00811727017499 K120763 000
00811727017482 K120763 000
00811727017475 K120763 000
00811727017468 K120763 000
00811727017451 K120763 000
00811727017543 K120763 000
B0760240B0 K120763 000
B0760249B0 K120763 000
B0760248B0 K120763 000
B0760247B0 K120763 000
B0760246B0 K120763 000
B0760245B0 K120763 000
B0760244B0 K120763 000
B0760243B0 K120763 000
B0760242B0 K120763 000
B0760241B0 K120763 000
00811727017444 K120763 000

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