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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase
Product CodeKQP
Regulation Number 862.1315
Device Class 2


Premarket Reviews
ManufacturerDecision
ASTORIA-PACIFIC,INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K101392  NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMET ...
  2.  K102643  SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
PERKINELMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-