The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Potassium Reagent Set, #1460.
| Device ID | K870033 |
| 510k Number | K870033 |
| Device Name: | AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Timothy J Belcastro |
| Correspondent | Timothy J Belcastro AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-01-21 |