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 Hematocrit, Tube, Rack, Sealer, Holder
510(k) Number K883185
Device Name SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
Applicant
Norfolk Scientific, Inc.
85 Morse St.
Norwood,  MA  02062
Applicant Contact THOMAS KELLEY
Correspondent
Norfolk Scientific, Inc.
85 Morse St.
Norwood,  MA  02062
Correspondent Contact THOMAS KELLEY
Regulation Number864.6400
Classification Product Code
GHY  
Date Received07/28/1988
Decision Date 08/18/1988
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
-
-