The following data is part of a premarket notification filed by Hypoguard Usa, Inc. with the FDA for Diascreen 50 Urine Chemistry Analyzer, Model # 1242-00; Diascreen Reagent Strip For Urinalysis, Cat. # D11000.
| Device ID | K010973 |
| 510k Number | K010973 |
| Device Name: | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 |
| 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 |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | KQO |
| Subsequent Product Code | KSL |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-09-11 |