510(k) K924062
K924062 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "MERITEC C. DIFFICILE CONTROLS". The FDA issued a decision of Substantially Equivalent on Oct 19, 1992. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Meridian Diagnostics, Inc. has 91 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 1992
- Date Received
- Aug 12, 1992
- 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
- 510(k) Exempt