510(k) K844479
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