CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT— 510(k) K860279
Substantially EquivalentBartels Immunodiagnostic Supplies, Inc.
FDA 510(k) clearance K860279 for CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT, Substantially Equivalent on 1986-05-13. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 2.
Clearance details
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Product code
- Code LIN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
Recent devices under product code LIN
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