510(k) K781304
K781304 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TRANSPORT MEDIA". The FDA issued a decision of Substantially Equivalent on Aug 14, 1978. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Bd Becton Dickinson Vacutainer Systems Preanalytic has 631 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 1978
- Date Received
- Jul 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type
- 510(k)