510(k) K922481

BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE by Board Of Directors, Albert Browne , Ltd. — Product Code JOJ

K922481 is an FDA 510(k) premarket notification submitted by Board Of Directors, Albert Browne , Ltd. for the device "BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE". The FDA issued a decision of Substantially Equivalent on Jun 2, 1994. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Board Of Directors, Albert Browne , Ltd. has 4 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 2, 1994
Date Received
May 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K922481. Report a data issue: hello@regdatalab.com.