510(k) K900571

AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) by American Research Products Co. — Product Code CIG

K900571 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)". The FDA issued a decision of Substantially Equivalent on Apr 16, 1990. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 16, 1990
Date Received
Feb 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type