BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY— 510(k) K924006
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K924006 for BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY, Substantially Equivalent on 1992-12-29. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code GNX
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Issauah, WA, US
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