510(k) K833447
K833447 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Bartels Immunodiagnostic Supplies, Inc. has 34 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1984
- Date Received
- Oct 5, 1983
- 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