Premarket Approval (PMA)

Note: 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.

• Device: RAPID POSITIVE MIC PANEL
• Generic Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Regulation Number: 866.1645
• Applicant: Dade Intl., Inc.; 1584 Enterprise Blvd.; West Sacramento, CA 95691
• PMA Number: P870049
• Supplement Number: S018
• Date Received: 04/21/1993
• Decision Date: 05/09/1994
• Reclassified Date: 05/06/2003
• Product Code: LON
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No