CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY— 510(k) K904329
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K904329 for CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY, Substantially Equivalent on 1991-03-12. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code MCB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
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