510(k) K862300

AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT by Amresco, Inc. — Product Code JGM

K862300 is an FDA 510(k) premarket notification submitted by Amresco, Inc. for the device "AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code JGM (Flame Photometry, Potassium), a Class II device regulated under 21 CFR 862.1600. Amresco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1986
Date Received
June 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type