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 K864740
Device Name BONE MARROW COLLECTION MEDIUM
Applicant
Bioclinical Laboratory Services, Inc.
9310 Hunting Valley Rd.
Clarence,  NY  14031
Applicant Contact FIKE, PHD
Correspondent
Bioclinical Laboratory Services, Inc.
9310 Hunting Valley Rd.
Clarence,  NY  14031
Correspondent Contact FIKE, PHD
Regulation Number864.2220
Classification Product Code
KIT  
Date Received12/04/1986
Decision Date 01/05/1987
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
-
-