TPLC - Total Product Life Cycle

Device	station, pipetting and diluting, for clinical use
Regulation Description	Pipetting and diluting system for clinical use.
Product Code	JQW
Regulation Number	862.2750
Device Class	1

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	3
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
BD
	SUBSTANTIALLY EQUIVALENT	1
Bio-Rad Laboratories
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC PRODUCTS
	SUBSTANTIALLY EQUIVALENT	5
HAMILTON
	SUBSTANTIALLY EQUIVALENT	6
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	2
Nichols Institute Diagnostics
	SUBSTANTIALLY EQUIVALENT	1
ORGANON-TEKNIKA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Malfunction	11
Computer software issue	5
Other (for use when an appropriate device code cannot be identified)	4
Component(s), worn	3
Component(s), broken	3
Low test results	3
False positive result	3
Component falling	2
Unknown (for use when the device problem is not known)	2
Device displays error message	2
Sharp/jagged/rough/etched/scratched	1
Error or warning message, failure to produce	1
False negative result	1
Low readings	1
Defective item	1
Mechanical issue	1
Mislabeled	1
Sensor problems	1
Smoking	1
Syringe, defective	1
Use of Device Issue	1
Vacuum, loss of	1
Improper or incorrect procedure or method	1
Total Device Problems	51