The following data is part of a premarket notification filed by Hypoguard Usa, Inc. with the FDA for Diascreen Reagent Strips For Urinalysis, Models D122oo (2gk), D12100 (1k), D11100 (1g).
| Device ID | K033851 |
| 510k Number | K033851 |
| Device Name: | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | HYPOGUARD USA, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Bruce Macfarlane |
| Correspondent | Bruce Macfarlane HYPOGUARD USA, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2004-03-02 |
| Summary: | summary |