JUSTONE

Manual Antimicrobial Susceptibility Test Systems

RADIOMETER AMERICA, INC.

The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Justone.

Pre-market Notification Details

• Device ID: K951240
• 510k Number: K951240
• Device Name: JUSTONE
• Classification: Manual Antimicrobial Susceptibility Test Systems
• Applicant: RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598
• Contact: Laura Koeth
• Correspondent: Laura Koeth; RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598
• Product Code: JWY
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-02-27
• Decision Date: 1995-10-07