EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Cyclosporine

FDA Premarket Approval P920031 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for emit(r) cyclosporine sample pretreatment reagent and cobas integra 700 cyclosporine.

• Device: EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
• Classification Name: Cyclosporine
• Generic Name: Cyclosporine
• Applicant: DADE BEHRING, INC.
• Date Received: 1999-07-02
• Decision Date: 2000-08-11
• PMA: P920031
• Supplement: S001
• Product Code: MKW
• Advisory Committee: Toxicology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• 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