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 |