510(k) K874178
K874178 is an FDA 510(k) premarket notification submitted by Otisville Biopharm, Inc. for the device "BIOTIS (TM) BCYE SELECTIVE". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Otisville Biopharm, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1987
- Date Received
- October 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Selective And Non-Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type