Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MICROSCAN RAPID FLUOROGENIC PANELS
• Classification Name: system, test, automated, antimicrobial susceptibility, short incubation
• Generic Name: antimicrobial susceptibility system
• Regulation Number: 866.1645
• Applicant: BAXTER HEALTHCARE CORP.
• PMA Number: P870049
• Supplement Number: S021
• Date Received: 09/13/1994
• Decision Date: 10/04/1994
• Product Code: LON [ Registered Establishments with LON ]
• Advisory Committee: Microbiology
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No