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 Calibrators, Drug Mixture
510(k) Number K893815
Device Name HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
Applicant
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact RON HOOVER
Correspondent
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact RON HOOVER
Regulation Number862.3200
Classification Product Code
DKB  
Date Received05/23/1989
Decision Date 07/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-