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 Diluent, Blood Cell
510(k) Number K821683
Device Name REAGENT FOR COULTER COUNTER MODEL 5+11
Applicant
Fisher Scientific Co., LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Fisher Scientific Co., LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.8200
Classification Product Code
GIF  
Date Received06/08/1982
Decision Date 06/24/1982
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
-
-