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, Phencyclidine
510(k) Number K020254
Device Name PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
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
Classification Product Code
LCM  
Date Received01/24/2002
Decision Date 05/10/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-