The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for First Choice(tm).
| Device ID | K912732 |
| 510k Number | K912732 |
| Device Name: | FIRST CHOICE(TM) |
| 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 | 1991-06-20 |
| Decision Date | 1991-09-10 |