The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbest Urinary Tract Infection Test Kit For Home-use.
| Device ID | K990873 |
| 510k Number | K990873 |
| Device Name: | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE |
| Classification | Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | K.c. Yee |
| Correspondent | K.c. Yee AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | JMT |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-09-01 |