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 Stains, Hematology
510(k) Number K760487
Device Name HEMASTAIN PHOSPHATE BUFFER
Applicant
Geometric Data, Div. Smithkline Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Geometric Data, Div. Smithkline Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.1850
Classification Product Code
KQC  
Date Received08/20/1976
Decision Date 08/30/1976
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
-
-