The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Pocketchem Ua Aution Sticks 10ta.
| Device ID | K022386 |
| 510k Number | K022386 |
| Device Name: | POCKETCHEM UA AUTION STICKS 10TA |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | ARKRAY, INC. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White ARKRAY, INC. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | JIL |
| Subsequent Product Code | JIP |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-22 |
| Decision Date | 2002-09-17 |
| Summary: | summary |