• 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 catalytic methods, amylase
Regulation Description Amylase test system.
Product CodeJFJ
Regulation Number 862.1070
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 1
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Incorrect or inadequate test results 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corp. II Feb-08-2008

-
-