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 K860282
Device Name RPMI 1640 W/GLUTAMINE W/HEPES
Applicant
NEWPORT BIOSYSTEMS, INC.
ROD ROBERTS
150 E. EDINGER, SUITE C
SANTA ANA,  CA  92705
Applicant Contact CULT INNOV
Correspondent
NEWPORT BIOSYSTEMS, INC.
ROD ROBERTS
150 E. EDINGER, SUITE C
SANTA ANA,  CA  92705
Correspondent Contact CULT INNOV
Regulation Number864.2220
Classification Product Code
KIT  
Date Received01/28/1986
Decision Date 02/05/1986
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
-
-