XN CHECK

Mixture, Hematology Quality Control

Streck

The following data is part of a premarket notification filed by Streck with the FDA for Xn Check.

Pre-market Notification Details

• Device ID: K120742
• 510k Number: K120742
• Device Name: XN CHECK
• Classification: Mixture, Hematology Quality Control
• Applicant: Streck 7002 SOUTH 109TH ST. Omaha, NE 68128
• Contact: Deborah S Kipp
• Correspondent: Deborah S Kipp; Streck 7002 SOUTH 109TH ST. Omaha, NE 68128
• Product Code: JPK
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-12
• Decision Date: 2012-10-19
• Summary: summary