AUTOLET

Device, Bleeding Time

ULSTER SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Autolet.

Pre-market Notification Details

• Device ID: K801815
• 510k Number: K801815
• Device Name: AUTOLET
• Classification: Device, Bleeding Time
• Applicant: ULSTER SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JCA
• CFR Regulation Number: 864.6100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-07-30
• Decision Date: 1980-10-10