510(k) K914123

SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS by Serim Research Corp. — Product Code LIF

K914123 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on April 9, 1992. The device falls under product code LIF (Dialyzer Reprocessing System), 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
April 9, 1992
Date Received
September 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type