The following data is part of a premarket notification filed by Applied Polytechnology, Inc. with the FDA for Filtra-check-uti.
| Device ID | K860483 |
| 510k Number | K860483 |
| Device Name: | FILTRA-CHECK-UTI |
| Classification | Kit, Screening, Urine |
| Applicant | APPLIED POLYTECHNOLOGY, INC. 8044 EL RIO Houston, TX 77054 |
| Contact | Claude C Longoria |
| Correspondent | Claude C Longoria APPLIED POLYTECHNOLOGY, INC. 8044 EL RIO Houston, TX 77054 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-10 |
| Decision Date | 1986-04-04 |