The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Bicarbonate Reagents Amresco Product #4326020.
| Device ID | K904007 |
| 510k Number | K904007 |
| Device Name: | BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Patel, Ph.d. |
| Correspondent | Patel, Ph.d. AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-09-13 |