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.

• Device: PreciseType TM HEA Molecular BeadChip test
• Classification Name: molecular erythrocyte typing test
• Generic Name: molecular erythrocyte typing test
• Applicant: BioArray Solutions, Ltd.; 35 technology drive suite 100; Warren , NJ 07059
• PMA Number: BP130026
• Supplement Number: S007
• Date Received: 03/22/2017
• Decision Date: 04/14/2017

• Decision: 30-Day Notice - No 135-Day Supplement Needed
• Product Code: PEP [ Registered Establishments with PEP ]
• Advisory Committee: Hematology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No