EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Cyclosporine

FDA Premarket Approval P920031

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the emit(r) 2000 cyclosporine specific assay. The device is indicated for in vitro diagnostic use on the roche diagnostics systems cobas mira, cobas mira s, and cobas mira plus chemistry systems for the quantitative analysis of cyclosporine (csa) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.

• Device: EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
• Classification Name: Cyclosporine
• Generic Name: Cyclosporine
• Applicant: DADE BEHRING, INC.
• Date Received: 1992-06-29
• Decision Date: 1996-10-02
• Notice Date: 1997-03-21
• PMA: P920031
• Supplement: S
• Product Code: MKW
• Docket Number: 97M-0082
• Advisory Committee: Toxicology
• Expedited Review: No
• Combination Product: No
• Applicant Address: DADE BEHRING, INC. po Box 6101 newark, DE 19714-6101

Supplemental Filings

Supplement Number	Date	Supplement Type
P920031		Original Filing
S003	2002-05-17	Normal 180 Day Track
S002	2002-02-20	Real-time Process
S001	1999-07-02	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00842768001475	P920031	000
00842768001468	P920031	000
00842768001482	P920031	001