XN CAL

Calibrator For Cell Indices

Streck

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

Pre-market Notification Details

• Device ID: K141962
• 510k Number: K141962
• Device Name: XN CAL
• Classification: Calibrator For Cell Indices
• 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: KRX
• CFR Regulation Number: 864.8150 [🔎]
• 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