PARA CHECK (AKA EIGHT CHECK-C)

Mixture, Hematology Quality Control

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para Check (aka Eight Check-c).

Pre-market Notification Details

• Device ID: K852992
• 510k Number: K852992
• Device Name: PARA CHECK (AKA EIGHT CHECK-C)
• Classification: Mixture, Hematology Quality Control
• Applicant: STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137
• Contact: Halvor Sornson
• Correspondent: Halvor Sornson; STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137
• Product Code: JPK
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-07-15
• Decision Date: 1985-10-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14987562460264	K852992	000