510(k) K001780
K001780 is an FDA 510(k) premarket notification submitted by Copan Diagnostics, Inc. for the device "COPAN VIRAL TRANSYSTEM". The FDA issued a decision of Substantially Equivalent on July 31, 2001. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Copan Diagnostics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2001
- Date Received
- June 13, 2000
- 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