PLATELETWORKS

System, Automated Platelet Aggregation

ARRAY MEDICAL, INC.

The following data is part of a premarket notification filed by Array Medical, Inc. with the FDA for Plateletworks.

Pre-market Notification Details

• Device ID: K990398
• 510k Number: K990398
• Device Name: PLATELETWORKS
• Classification: System, Automated Platelet Aggregation
• Applicant: ARRAY MEDICAL, INC. ONE HARVARD WAY, SUITE 5 HILLSBOROUGH CAMPUS Somerville, NJ 08876
• Contact: David Carville
• Correspondent: David Carville; ARRAY MEDICAL, INC. ONE HARVARD WAY, SUITE 5 HILLSBOROUGH CAMPUS Somerville, NJ 08876
• Product Code: JOZ
• CFR Regulation Number: 864.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-09
• Decision Date: 1999-12-01
• Summary: summary