EZ VIEW

System, Blood Culturing

DIFCO LABORATORIES, INC.

The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Ez View.

Pre-market Notification Details

• Device ID: K925693
• 510k Number: K925693
• Device Name: EZ VIEW
• Classification: System, Blood Culturing
• Applicant: DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104
• Contact: David W Gates
• Correspondent: David W Gates; DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104
• Product Code: MDB
• CFR Regulation Number: 866.2560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-12
• Decision Date: 1993-01-15