510(k) K904329
K904329 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Mar 12, 1991. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 12, 1991
- Date Received
- Sep 20, 1990
- 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