The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Amresco Flow Pac Sma Phosphate Buffer Concentrate.
| Device ID | K851923 |
| 510k Number | K851923 |
| Device Name: | AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | AMRESCO, INC. P.O. BOX 21009 South Euclid, OH 44121 |
| Contact | Timothy J Belcastro |
| Correspondent | Timothy J Belcastro AMRESCO, INC. P.O. BOX 21009 South Euclid, OH 44121 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-02 |
| Decision Date | 1985-05-24 |