510(k) K844479

CHEMSPOR by American Sterilizer Co. — Product Code FRC

K844479 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "CHEMSPOR". The FDA issued a decision of SN on November 25, 1985. The device falls under product code FRC (Indicator, Biological 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
SN ()
Decision Date
November 25, 1985
Date Received
November 19, 1984
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