The following data is part of a premarket notification filed by Applied Polytechnology, Inc. with the FDA for Bacteriuria Detect. Device Aptek Ii.
| Device ID | K843834 |
| 510k Number | K843834 |
| Device Name: | BACTERIURIA DETECT. DEVICE APTEK II |
| Classification | Kit, Screening, Urine |
| Applicant | APPLIED POLYTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Claude C Longoria |
| Correspondent | Claude C Longoria APPLIED POLYTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1984-11-29 |