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 System, Hemoglobin, Automated
510(k) Number K771789
Device Name BLANKING SOLUTION HGB
Applicant
J.T. Baker Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
J.T. Baker Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5620
Classification Product Code
GKR  
Date Received09/20/1977
Decision Date 10/07/1977
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
-
-