510(k) K051056

VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR by Albert Browne , Ltd. — Product Code FRC

K051056 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on October 20, 2005. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Albert Browne , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2005
Date Received
April 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type