BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA— 510(k) K922334
Substantially EquivalentBaxter Diagnostics, Inc.
FDA 510(k) clearance K922334 for BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA, Substantially Equivalent on 1992-12-15. Applicant: Baxter Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Baxter Diagnostics, Inc.
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
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