GEM Premier ChemSTAT

Electrode, Ion Specific, Sodium

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: K183549
• 510k Number: K183549
• Device Name: GEM Premier ChemSTAT
• Classification: Electrode, Ion Specific, Sodium
• 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: JGS
• Subsequent Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: JFP
• Subsequent Product Code: JJE
• CFR Regulation Number: 862.1665 [🔎]
• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08426951070848	K183549	000
08426951070831	K183549	000
08426951070824	K183549	000
08426951070817	K183549	000
08426951070800	K183549	000
08426951070794	K183549	000
08426951070787	K183549	000
08426951070770	K183549	000