510(k) K860178
K860178 is an FDA 510(k) premarket notification submitted by Ncs Diagnostics, Inc. for the device "KULTSURE (CULTURE TRANSPORT)". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Ncs Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1986
- Date Received
- January 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Non-Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type