GEM Premier ChemSTAT

Enzymatic Method, Creatinine

Instrumentation Laboratory Co.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier Chemstat.

Pre-market Notification Details

• Device ID: K183555
• 510k Number: K183555
• Device Name: GEM Premier ChemSTAT
• Classification: Enzymatic Method, Creatinine
• Applicant: Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730
• Contact: Gabriella Erdosy
• Correspondent: Gabriella Erdosy; Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730
• Product Code: JFY
• Subsequent Product Code: CDQ
• Subsequent Product Code: KHS
• CFR Regulation Number: 862.1225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-20
• Decision Date: 2019-02-16
• Summary: summary