The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Amresco Flow Pac Sodium Potassium Reagent.
Device ID | K862300 |
510k Number | K862300 |
Device Name: | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT |
Classification | Flame Photometry, Potassium |
Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
Contact | Timothy J Belcastro |
Correspondent | Timothy J Belcastro AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
Product Code | JGM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-17 |
Decision Date | 1986-07-29 |