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 Control, Plasma, Abnormal
510(k) Number K930959
Device Name FACTOR CONTROL [P]
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact LOE B LE
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact LOE B LE
Regulation Number864.5425
Classification Product Code
GGC  
Date Received02/24/1993
Decision Date 05/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-