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 mixture, control, white-cell and red-cell indices
Product CodeGLQ
Regulation Number 864.8625
Device Class 2


Premarket Reviews
ManufacturerDecision
STRECK
  SUBSTANTIALLY EQUIVALENT 4
  1.  K090137  STAK-CHEX PLUS RETICS
  2.  K101335  CELL-CHEX
  3.  K110718  CELL-CHEX WITH CPPD CRYSTALS
  4.  K111211  CELL-DYN 22 PLUS CONTROL

-
-