Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K020368
Device Name OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)
Applicant
Lin-Zhi International, Inc.
2391 Zanker Rd., Suite 340
San Jose,  CA  95131 -1124
Applicant Contact CHIU CHIN CHANG
Correspondent
Lin-Zhi International, Inc.
2391 Zanker Rd., Suite 340
San Jose,  CA  95131 -1124
Correspondent Contact CHIU CHIN CHANG
Regulation Number862.3650
Classification Product Code
DJG  
Date Received02/04/2002
Decision Date 06/04/2002
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
-
-