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: K141964
• 510k Number: K141964
• Device Name: XN CHECK
• Classification: Mixture, Hematology Quality Control
• Applicant: Streck 7002 SOUTH 109TH ST. La Vista, NE 68128
• Contact: Deborah Kipp
• Correspondent: Deborah Kipp; Streck 7002 SOUTH 109TH ST. La Vista, 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: 2014-07-18
• Decision Date: 2014-12-05
• Summary: summary