The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Sodium Potassium Reagent Set.
| Device ID | K861967 |
| 510k Number | K861967 |
| Device Name: | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-13 |