XN-L CHECK

Mixture, Hematology Quality Control

STRECK

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

Pre-market Notification Details

• Device ID: K160586
• 510k Number: K160586
• Device Name: XN-L CHECK
• Classification: Mixture, Hematology Quality Control
• Applicant: STRECK 7002 SOUTH 109TH STREET Omaha, NE 68128
• Contact: Deborah Kipp
• Correspondent: Deborah Kipp; STRECK 7002 SOUTH 109TH STREET 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: 2016-03-01
• Decision Date: 2016-12-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14987562460394	K160586	000