ISOSCAN

Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Isoscan.

Pre-market Notification Details

• Device ID: K944185
• 510k Number: K944185
• Device Name: ISOSCAN
• Classification: Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
• Applicant: ISOLAB, INC. DRAWER 4350 Akron, OH 44321
• Contact: Janet D Perkins
• Correspondent: Janet D Perkins; ISOLAB, INC. DRAWER 4350 Akron, OH 44321
• Product Code: JQT
• CFR Regulation Number: 862.2400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-26
• Decision Date: 1994-11-17