510(k) K820411

LIQUIZYME CHLORIDE REAGENT by American Research Products Co. — Product Code JFS

K820411 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "LIQUIZYME CHLORIDE REAGENT". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type