The following data is part of a premarket notification filed by Dia-screen Corp. with the FDA for Diascreen Reagent Strips.
| Device ID | K971976 |
| 510k Number | K971976 |
| Device Name: | DIASCREEN REAGENT STRIPS |
| Classification | Test, Urine Leukocyte |
| Applicant | DIA-SCREEN CORP. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Vicki Frawley |
| Correspondent | Vicki Frawley DIA-SCREEN CORP. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | LJX |
| Subsequent Product Code | JNA |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 864.7675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-06-17 |
| Summary: | summary |