510(k) K900666

AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 by American Research Products Co. — Product Code CGX

K900666 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791". The FDA issued a decision of Substantially Equivalent on April 19, 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
April 19, 1990
Date Received
February 13, 1990
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