The following data is part of a premarket notification filed by Pochemco, Inc. with the FDA for Aldetect.
| Device ID | K905779 |
| 510k Number | K905779 |
| Device Name: | ALDETECT |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | POCHEMCO, INC. 861 MEADOW ST. Chicopee, MA 01013 |
| Contact | Jerry Poch |
| Correspondent | Jerry Poch POCHEMCO, INC. 861 MEADOW ST. Chicopee, MA 01013 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-05-23 |