510(k) K952215

SERIM HISENSE TEST KIT by Serim Research Corp. — Product Code FIP

K952215 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM HISENSE TEST KIT". The FDA issued a decision of Substantially Equivalent on August 9, 1995. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Serim Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1995
Date Received
May 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type