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 radioimmunoassay, androstenedione
510(k) Number K854650
Device Name DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Applicant Contact GOPAL SAVJANI
Correspondent
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Correspondent Contact GOPAL SAVJANI
Regulation Number862.1075
Classification Product Code
CIZ  
Date Received11/19/1985
Decision Date 12/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-