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 Urinalysis Controls (Assayed And Unassayed)
510(k) Number K070848
Device Name LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
Applicant
BIO-RAD, DIAGNOSTICS GRP.
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD, DIAGNOSTICS GRP.
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJW  
Date Received03/28/2007
Decision Date 04/25/2007
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
Predetermined Change
Control Plan Authorized		 No
-
-