TPLC - Total Product Life Cycle

show TPLC since

Device	susceptibility test discs, antimicrobial
Product Code	JTN
Regulation Number	866.1620
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECTON DICKINSON AND COMPANY (BD)
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON, AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	3
HARDY DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	15
1. K093807 HARDYDISK AST TELAVANCIN,30UG
2. K103538 HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
3. K152838 HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA ...
4. K152846 HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C ...
5. K170127 HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
6. K171975 HardyDisk AST Delafloxacin 5 µg (DLX5)
7. K172621 HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
8. K181700 HardyDisk AST Plazomicin 30ug (PLZ30)
9. K182357 HardyDisk AST Eravacycline 20µg (ERV20)
10. K183298 HardyDisk AST Omadacycline 30µg (OMC30)
11. K191931 HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/2 ...
12. K192326 HardyDisk AST Lefamulin 20µg (LMU20)
13. K193504 HardyDisk AST Cefiderocol 30ug (FDC30)
14. K230827 HardyDisk AST Rezafungin 5µg (RZF5)
15. K231568 HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20 ...
OXOID LIMITED (PART OF THERMO FISHER SCIENTIFIC)
	SUBSTANTIALLY EQUIVALENT	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Markings/Labelling Problem	10	10
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	17	17
No Consequences Or Impact To Patient	1	1