510(k) K170602
K170602 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "Continuous Single Culture-NX Complete (CSCM-NXC)". The FDA issued a decision of Substantially Equivalent on Jun 7, 2017. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Irvine Scientific Sales Co., Inc. has 39 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 2017
- Date Received
- Mar 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type
- 510(k)