LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS

Enzyme Immunoassay, Amphetamine

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls.

Pre-market Notification Details

Device IDK102210
510k NumberK102210
Device Name:LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
ClassificationEnzyme Immunoassay, Amphetamine
Applicant Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale,  CA  94085
ContactBernice Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale,  CA  94085
Product CodeDKZ  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-05
Decision Date2010-12-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B07601080 K102210 000
00811727016546 K102210 000
00811727016553 K102210 000
00811727016560 K102210 000
00811727016577 K102210 000
00811727016584 K102210 000
00811727016591 K102210 000
00811727016607 K102210 000
B07601000 K102210 000
B07601010 K102210 000
B07601020 K102210 000
B07601030 K102210 000
B07601040 K102210 000
B07601050 K102210 000
B07601070 K102210 000
00811727016539 K102210 000

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