510(k) K896686

AMRESCO CREATININE REAGENT #4316100 by American Research Products Co. — Product Code CGX

K896686 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO CREATININE REAGENT #4316100". The FDA issued a decision of Substantially Equivalent on February 8, 1990. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1990
Date Received
November 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type