• 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 culture media, non-propagating transport
Regulation Description Transport culture medium.
Product CodeJSM
Regulation Number 866.2390
Device Class 1


Premarket Reviews
ManufacturerDecision
COPAN ITALIA S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
GREINER BIO-ONE NA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL CHEMICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
PURITAN MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Leak / Splash 39
Incorrect, Inadequate or Imprecise Result or Readings 38
Material Protrusion / Extrusion 34
Incorrect Or Inadequate Test Results 19
Short Fill 14
Volume Accuracy Problem 11
Delivered as Unsterile Product 11
Device Markings / Labelling Problem 8
Device Contamination with Chemical or Other Material 6
Component Missing 4
Product Quality Problem 3
Material Deformation 2
Use of Device Problem 2
Detachment Of Device Component 2
Contamination / decontamination Problem 2
Material Discolored 1
Appropriate Term/Code Not Available 1
Difficult to Insert 1
Detachment of Device or device Component 1
Packaging Problem 1
Material Twisted / Bent 1
Complete Blockage 1
Total Device Problems 202


-
-