The following data is part of a premarket notification filed by Polymer Technology Intl. with the FDA for First Choice Test Strip.
| Device ID | K950628 |
| 510k Number | K950628 |
| Device Name: | FIRST CHOICE TEST STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD. Issaquah, WA 98027 |
| Contact | Rob Ngungu |
| Correspondent | Rob Ngungu POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD. 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 | 1995-02-13 |
| Decision Date | 1995-11-08 |