510(k) K112048
K112048 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "IMMUNOCARD C. DIFFICILE GDH". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2011
- Date Received
- July 18, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, C. Difficile
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type