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: 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
• Supplement Number: S011
• Date Received: 04/05/1983
• Decision Date: 07/25/1983
• Reclassified Date: 05/06/2003
• Product Code: LTT
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No