510(k) K844571
K844571 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE". The FDA issued a decision of Substantially Equivalent on January 30, 1985. The device falls under product code KZJ (Device, Gas Generating), a Class I device regulated under 21 CFR 866.2580. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1985
- Date Received
- November 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Gas Generating
- Device Class
- Class I
- Regulation Number
- 866.2580
- Review Panel
- MI
- Submission Type