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 Calibrator, Secondary
510(k) Number K060322
Device Name CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
Applicant
CLINIQA CORPORATION
1432-B SOUTH MISSION RD.
FALLBROOK,  CA  92028
Applicant Contact CAROL RUGGIERO
Correspondent
CLINIQA CORPORATION
1432-B SOUTH MISSION RD.
FALLBROOK,  CA  92028
Correspondent Contact CAROL RUGGIERO
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJY  
Date Received02/09/2006
Decision Date 03/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-