Premarket Approval (PMA)

Note: 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.

• Device: MIC ANTIBIOTIC TEST PANELS
• Generic Name: Panels, test, susceptibility, antimicrobial
• Regulation Number: 866.1640
• Applicant: Pasco Laboratories, Inc.; 12750 W. 42nd Ave.; Wheat Ridge, CO 80033
• PMA Number: N50494
• Date Received: 05/01/1977
• Decision Date: 04/25/1980
• Reclassified Date: 05/06/2003
• Product Code: LTT
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Supplements: S003 S004 S005 S006 S007 S008 S009 S010 S011