• 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 Back To Search Results
Device radioimmunoassay, 17-hydroxyprogesterone
Regulation Description 17-Hydroxyprogesterone test system.
Product CodeJLX
Regulation Number 862.1395
Device Class 1


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
  1.  K860335  COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
  2.  K874782  COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT

Device Problems
Contamination of device ingredient or reagent 1
Total Device Problems 1

-
-