The following data is part of a premarket notification filed by Genesis Labs, Inc. with the FDA for Dia Screen 10 Way Reagent Strips.
| Device ID | K961375 |
| 510k Number | K961375 |
| Device Name: | DIA SCREEN 10 WAY REAGENT STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | GENESIS LABS, INC. 5183 W. 76TH ST. Minneapolis, MN 55435 |
| Contact | John Murray |
| Correspondent | John Murray GENESIS LABS, INC. 5183 W. 76TH ST. Minneapolis, MN 55435 |
| Product Code | JIL |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-06-18 |
| Summary: | summary |