STA COMPACT MAX

System, Multipurpose For In Vitro Coagulation Studies

DIAGNOSTICA STAGO, INCORPORATED

The following data is part of a premarket notification filed by Diagnostica Stago, Incorporated with the FDA for Sta Compact Max.

Pre-market Notification Details

• Device ID: K130090
• 510k Number: K130090
• Device Name: STA COMPACT MAX
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: DIAGNOSTICA STAGO, INCORPORATED PIAZZA ALBANIA, 10 Rome, IT 00153
• Contact: Carlo D'alessandro
• Correspondent: Carlo D'alessandro; DIAGNOSTICA STAGO, INCORPORATED PIAZZA ALBANIA, 10 Rome, IT 00153
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-14
• Decision Date: 2013-02-12
• Summary: summary