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 K991698
Device Name REDI-TEST PCP
Applicant
Redwood Biotech, Inc.
2440 Leghorn St.
Mountian View,  CA  94043
Applicant Contact JANIS FREESTONE
Correspondent
Redwood Biotech, Inc.
2440 Leghorn St.
Mountian View,  CA  94043
Correspondent Contact JANIS FREESTONE
Classification Product Code
LCM  
Date Received05/18/1999
Decision Date 08/25/1999
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
-
-