BARTELS EPSTEIN-BARR VIRUS IGG EIA— 510(k) K922332
Substantially EquivalentBaxter Diagnostics, Inc.
FDA 510(k) clearance K922332 for BARTELS EPSTEIN-BARR VIRUS IGG EIA, Substantially Equivalent on 1992-09-02. Applicant: Baxter Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Baxter Diagnostics, Inc.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
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More clearances from Baxter Diagnostics, Inc.
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