FIRST CHOICE

Glucose Oxidase, Glucose

POLYMER TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for First Choice.

Pre-market Notification Details

• Device ID: K912580
• 510k Number: K912580
• Device Name: FIRST CHOICE
• Classification: Glucose Oxidase, Glucose
• Applicant: POLYMER TECHNOLOGY CORP. 1595 NW GILMAN BLVD. SUITE 17 Issaquah, WA 98027
• Contact: Terry G Kelley
• Correspondent: Terry G Kelley; POLYMER TECHNOLOGY CORP. 1595 NW GILMAN BLVD. SUITE 17 Issaquah, WA 98027
• Product Code: CGA
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-06-12
• Decision Date: 1992-03-04