SICKLE-CHEX

Test, Sickle Cell

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Sickle-chex.

Pre-market Notification Details

• Device ID: K013316
• 510k Number: K013316
• Device Name: SICKLE-CHEX
• Classification: Test, Sickle Cell
• Applicant: STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128
• Contact: Paul Kittelson
• Correspondent: Paul Kittelson; STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128
• Product Code: GHM
• CFR Regulation Number: 864.7825 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-04
• Decision Date: 2001-11-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844509000891	K013316	000
00844509000884	K013316	000