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 Counter, Cell, Automated (Particle Counter)
510(k) Number K854678
Device Name ERMA PC-602 PC-603 BLOOD CELL COUNTER
Applicant
Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Applicant Contact MORAD DAYOUDZADEH
Correspondent
Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Correspondent Contact MORAD DAYOUDZADEH
Regulation Number864.5200
Classification Product Code
GKL  
Date Received12/05/1985
Decision Date 02/24/1986
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
-
-