510(k) K854222

DIESSE RF TEST KIT by Marvic Interpharma, Inc. — Product Code DHR

K854222 is an FDA 510(k) premarket notification submitted by Marvic Interpharma, Inc. for the device "DIESSE RF TEST KIT". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Marvic Interpharma, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1986
Date Received
October 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type