OPTICLEAR

Apparatus, Electrophoresis, For Clinical Use

GELMAN SCIENCES, INC.

The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Opticlear.

Pre-market Notification Details

• Device ID: K842485
• 510k Number: K842485
• Device Name: OPTICLEAR
• Classification: Apparatus, Electrophoresis, For Clinical Use
• Applicant: GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JJN
• CFR Regulation Number: 862.2485 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-06-25
• Decision Date: 1984-08-10