510(k) K922485

CHEMDI-VHP CHEMICAL INDICATOR by American Sterilizer Co. — Product Code JOJ

K922485 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "CHEMDI-VHP CHEMICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on September 29, 1993. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1993
Date Received
May 18, 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