510(k) K812945

LIQUILYME BUN REAGENT by Amresco, Inc. — Product Code LFP

K812945 is an FDA 510(k) premarket notification submitted by Amresco, Inc. for the device "LIQUILYME BUN REAGENT". The FDA issued a decision of Substantially Equivalent on November 6, 1981. The device falls under product code LFP (Conductivity Rate, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Amresco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conductivity Rate, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type