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 radioassay, vitamin b12
510(k) Number K941235
Device Name VISTA B12 ASSAY
Applicant
SYVA CO.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
SYVA CO.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number862.1810
Classification Product Code
CDD  
Date Received03/15/1994
Decision Date 08/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-