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 K871698
Device Name RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
Applicant
Immunalysis Corporation
1707 Gardena Ave.
Glendale,  CA  91204
Applicant Contact SOARES, PHD
Correspondent
Immunalysis Corporation
1707 Gardena Ave.
Glendale,  CA  91204
Correspondent Contact SOARES, PHD
Regulation Number862.3650
Classification Product Code
DJG  
Date Received04/28/1987
Decision Date 06/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-