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: UNISCEPT(TM)
• Generic Name: Manual antimicrobial susceptibility test systems
• Regulation Number: 866.1640
• Applicant: Analytical Products, Inc.; 200 Express St.; Plainview, NY 11803
• PMA Number: P830028
• Supplement Number: S001
• Date Received: 01/25/1984
• Decision Date: 03/09/1984
• Reclassified Date: 05/06/2003
• Product Code: JWY
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No