The following data is part of a premarket notification filed by Stephens Scientific with the FDA for Ameri Clear.
| Device ID | K832011 |
| 510k Number | K832011 |
| Device Name: | AMERI CLEAR |
| Classification | Agent, Clearing |
| Applicant | STEPHENS SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-23 |
| Decision Date | 1983-08-12 |