510(k) K830363
K830363 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC 170 TRYPTIC SOY BROTH W/RESINS". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code LJF (Device, Antimicrobial Drug Removal), a Class I device regulated under 21 CFR 866.2560. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- February 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Antimicrobial Drug Removal
- Device Class
- Class I
- Regulation Number
- 866.2560
- Review Panel
- MI
- Submission Type