• 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 K052788
Device Name N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Applicant Contact KATHLEEN A DRAY-LYONS
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Correspondent Contact KATHLEEN A DRAY-LYONS
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIX   JJY  
Date Received10/03/2005
Decision Date 03/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-