510(k) K855205
K855205 is an FDA 510(k) premarket notification submitted by Hana Biologics, Inc. for the device "MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 1986. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Hana Biologics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1986
- Date Received
- December 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type