POLYPET

Device, Microtiter Diluting/dispensing

INSTRUMED, INC.

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

Pre-market Notification Details

• Device ID: K860617
• 510k Number: K860617
• Device Name: POLYPET
• Classification: Device, Microtiter Diluting/dispensing
• Applicant: INSTRUMED, INC. P.O. BOX N Union Bridge, MD 21791
• Contact: Medicus, Phd
• Correspondent: Medicus, Phd; INSTRUMED, INC. P.O. BOX N Union Bridge, MD 21791
• Product Code: JTC
• CFR Regulation Number: 866.2500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-02-19
• Decision Date: 1986-03-03