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 Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K964698
Device Name SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
Applicant
Andwin Scientific
1219 E. Bridletrail Rd.
Draper,  UT  84020 -8523
Applicant Contact A. THOMAS DOYLE
Correspondent
Andwin Scientific
1219 E. Bridletrail Rd.
Draper,  UT  84020 -8523
Correspondent Contact A. THOMAS DOYLE
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Codes
GJE   LYY  
Date Received11/22/1996
Decision Date 03/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-