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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Propoxyphene
510(k) Number K023795
Device Name PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
Applicant
Lin-Zhi International, Inc.
2391 Zanker Rd. Suite 340
San Jose,  CA  95131
Applicant Contact CHIU CHIN CHANG
Correspondent
Lin-Zhi International, Inc.
2391 Zanker Rd. Suite 340
San Jose,  CA  95131
Correspondent Contact CHIU CHIN CHANG
Regulation Number862.3700
Classification Product Code
JXN  
Date Received11/13/2002
Decision Date 01/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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