ROTAVIRUS LATEX AGGLUTINATION ASSAY— 510(k) K861172
Substantially EquivalentBartels Immunodiagnostic Supplies, Inc.
FDA 510(k) clearance K861172 for ROTAVIRUS LATEX AGGLUTINATION ASSAY, Substantially Equivalent on 1986-07-01. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.
Clearance details
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Product code
- Code LIQ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3405
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
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