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 Clinical Sample Concentrator
510(k) Number K870690
Device Name CENTRIPREP CONCENTRATOR
Applicant
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact JAMES M DELANEY
Correspondent
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact JAMES M DELANEY
Regulation Number862.2310
Classification Product Code
JJH  
Date Received02/19/1987
Decision Date 03/19/1987
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
-
-