• 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 mixture, hematology quality control
510(k) Number K760682
Device Name 4C ABNORMAL LOW-HIGH (8 X 6 M1)
Applicant
COULTER ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COULTER ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.8625
Classification Product Code
JPK  
Date Received09/20/1976
Decision Date 10/08/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-