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 Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K883445
Device Name HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012
Applicant
J R SCIENTIFIC
ONE HARTER AVE., SUITE B
P.O. BOX 1937
WOODLAND,  CA  95695
Applicant Contact G KONISH,PHD
Correspondent
J R SCIENTIFIC
ONE HARTER AVE., SUITE B
P.O. BOX 1937
WOODLAND,  CA  95695
Correspondent Contact G KONISH,PHD
Regulation Number864.2220
Classification Product Code
KIT  
Date Received08/15/1988
Decision Date 08/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-