510(k) K854449
K854449 is an FDA 510(k) premarket notification submitted by R. Kent Richards, Inc. for the device "HEKTOEN ENTERIC AGAR". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. R. Kent Richards, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1985
- Date Received
- November 5, 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