510(k) K901734

SERIM RESIDUAL CHLORINE TEST KIT by Serim Research Corp. — Product Code FKJ

K901734 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM RESIDUAL CHLORINE TEST KIT". The FDA issued a decision of Substantially Equivalent on September 13, 1990. The device falls under product code FKJ (Filter, Blood, Dialysis), a Class II device regulated under 21 CFR 876.5820. Serim Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1990
Date Received
April 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type