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 Urinary Homocystine (Nonquantitative) Test System
510(k) Number K062808
Device Name LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
Applicant
Catch Incorporated
21031 SE 202nd St.
Renton,  WA  98058
Applicant Contact Cindy Green
Correspondent
Catch Incorporated
21031 SE 202nd St.
Renton,  WA  98058
Correspondent Contact Cindy Green
Regulation Number862.1377
Classification Product Code
LPS  
Date Received09/19/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-