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, Vacuum Sample, With Anticoagulant
510(k) Number K861449
Device Name VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
Applicant
Exel Intl.
2300 E. Oakland Park Blvd.,
Suite 205/6
Fort Lauderdale,  FL  33306
Applicant Contact ESHAGH HAMID
Correspondent
Exel Intl.
2300 E. Oakland Park Blvd.,
Suite 205/6
Fort Lauderdale,  FL  33306
Correspondent Contact ESHAGH HAMID
Regulation Number862.1675
Classification Product Code
GIM  
Date Received04/17/1986
Decision Date 09/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-