RETIC-CHEX

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 Retic-chex.

Pre-market Notification Details

• Device ID: K843093
• 510k Number: K843093
• Device Name: RETIC-CHEX
• Classification: Mixture, Hematology Quality Control
• Applicant: STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137
• Contact: Hal Sornson
• Correspondent: Hal 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: 1984-08-07
• Decision Date: 1984-10-23