HYCEL M

Analyzer, Chemistry, Micro, For Clinical Use

HYCEL, INC.

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

Pre-market Notification Details

• Device ID: K790335
• 510k Number: K790335
• Device Name: HYCEL M
• Classification: Analyzer, Chemistry, Micro, For Clinical Use
• Applicant: HYCEL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JJF
• CFR Regulation Number: 862.2170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-02-21
• Decision Date: 1979-02-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613336164884	K790335	000