The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbest Reagent Strip For Urinalysis.
| Device ID | K973142 |
| 510k Number | K973142 |
| Device Name: | DBEST REAGENT STRIP FOR URINALYSIS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| 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 | 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 | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-21 |
| Decision Date | 1997-10-20 |