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 Enzyme Immunoassay, Propoxyphene
510(k) Number K011163
Device Name MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
Applicant
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact SUSAN COLLINS
Correspondent
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact SUSAN COLLINS
Regulation Number862.3700
Classification Product Code
JXN  
Date Received04/16/2001
Decision Date 05/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-