The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Amresco Subst Concen, Pro #2432,buf,nad,2455,tri.
| Device ID | K852948 |
| 510k Number | K852948 |
| Device Name: | AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-11 |
| Decision Date | 1985-08-07 |