510(k) K852192
K852192 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DISPOSABLE STEAM BIOLOGICAL TEST PACK". The FDA issued a decision of Substantially Equivalent on November 1, 1985. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Parke-Davis Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1985
- Date Received
- May 20, 1985
- 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