ROTAVIRUS LATEX AGGLUTINATION ASSAY— 510(k) K861172

Substantially Equivalent

Bartels Immunodiagnostic Supplies, Inc.

FDA 510(k) clearance K861172 for ROTAVIRUS LATEX AGGLUTINATION ASSAY, Substantially Equivalent on 1986-07-01. Applicant: Bartels Immunodiagnostic Supplies, Inc..

Clearance details

Applicant: Bartels Immunodiagnostic Supplies, Inc.
Product code: Code LIQ
Advisory panel: Microbiology
Date received: 1986-03-28
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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