X-CAL

Calibrator For Cell Indices

Streck

The following data is part of a premarket notification filed by Streck with the FDA for X-cal.

Pre-market Notification Details

• Device ID: K083200
• 510k Number: K083200
• Device Name: X-CAL
• Classification: Calibrator For Cell Indices
• Applicant: Streck 7002 SOUTH 109TH ST. Omaha, NE 68128
• Contact: Erin Johnson
• Correspondent: Erin Johnson; Streck 7002 SOUTH 109TH ST. Omaha, 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: 2008-10-30
• Decision Date: 2009-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14987562460592	K083200	000
14987562460585	K083200	000