The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for Ucd Urine Specimen Collector.
| Device ID | K854173 |
| 510k Number | K854173 |
| Device Name: | UCD URINE SPECIMEN COLLECTOR |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | BAKER INSTRUCTIONS CORP. 100 CASCADE DR. P.O. BOX 2168 Allentown, PA 18001 |
| Contact | Tomalesky |
| Correspondent | Tomalesky BAKER INSTRUCTIONS CORP. 100 CASCADE DR. P.O. BOX 2168 Allentown, PA 18001 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1985-11-04 |