COBAS INTEGRA CYCLOSPORINE

Cyclosporine

FDA Premarket Approval P920031 S002

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 to expand the use of the cobas integra cyclosporing reagent system to the cobas integra 400 and cobas integra 800 analyzers.

• Device: COBAS INTEGRA CYCLOSPORINE
• Classification Name: Cyclosporine
• Generic Name: Cyclosporine
• Applicant: DADE BEHRING, INC.
• Date Received: 2002-02-20
• Decision Date: 2002-02-26
• PMA: P920031
• Supplement: S002
• Product Code: MKW
• Advisory Committee: Toxicology
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• 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