The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Sani Catch Ba.
| Device ID | K833814 |
| 510k Number | K833814 |
| Device Name: | SANI CATCH BA |
| Classification | Device, Specimen Collection |
| Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-02 |
| Decision Date | 1984-03-19 |