TPLC - Total Product Life Cycle

• Device: colorimeter, photometer, spectrophotometer for clinical use
• Regulation Description: Colorimeter, photometer, or spectrophotometer for clinical use.
• Product Code: JJQ
• Regulation Number: 862.2300
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	9
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	6
Bio-Rad Laboratories
	SUBSTANTIALLY EQUIVALENT	1
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	4
DIGENE CORP.
	SUBSTANTIALLY EQUIVALENT	1
DOW
	SUBSTANTIALLY EQUIVALENT	2
EASTMAN KODAK
	SUBSTANTIALLY EQUIVALENT	1
EMD
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	4
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
KULZER
	SUBSTANTIALLY EQUIVALENT	2
Nichols Institute Diagnostics
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	1
QUIDEL CORP.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
TOSOH CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Smoking	6
Other (for use when an appropriate device code cannot be identified)	2
Low test results	1
Defective item	1
Use of Device Issue	1
Electrical issue	1
Total Device Problems	12

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	2	0	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	BioTek Instruments, Inc.	II	Sep-18-2009
2	Diasorin Inc.	II	Mar-30-2009
3	Otsuka America Pharmaceutical, Inc.	II	Sep-01-2008