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 Centrifuge, Hematocrit
510(k) Number K961803
Device Name SPUNCRIT (MODEL DRC-40)
Applicant
Micro Diagnostics Corp.
170-57 S. Commerce Way
Bethlehem,  PA  18017
Applicant Contact RODNEY A KATZER
Correspondent
Micro Diagnostics Corp.
170-57 S. Commerce Way
Bethlehem,  PA  18017
Correspondent Contact RODNEY A KATZER
Regulation Number864.6400
Classification Product Code
GKG  
Date Received05/09/1996
Decision Date 07/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-