The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Random Access Liquid #4901030.
| Device ID | K881056 |
| 510k Number | K881056 |
| Device Name: | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 |
| Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Sharon Fiorina |
| Correspondent | Sharon Fiorina AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | JJC |
| CFR Regulation Number | 862.2150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-11 |
| Decision Date | 1988-11-15 |