OMNI

Colorimeter, Photometer, Spectrophotometer For Clinical Use

BIO-TEK INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Omni.

Pre-market Notification Details

• Device ID: K925625
• 510k Number: K925625
• Device Name: OMNI
• Classification: Colorimeter, Photometer, Spectrophotometer For Clinical Use
• Applicant: BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404
• Contact: Michael N Sevigny
• Correspondent: Michael N Sevigny; BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404
• Product Code: JJQ
• CFR Regulation Number: 862.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-06
• Decision Date: 1993-08-19