GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT— 510(k) K870176

Name: FDA 510(k) clearance K870176
Creator: U.S. Food and Drug Administration
Published: 1987-07-16

Substantially Equivalent

Genetic Systems Corp.

FDA 510(k) clearance K870176 for GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT, Substantially Equivalent on 1987-07-16. Applicant: Genetic Systems Corp.. Device class: 1.

Clearance details

Applicant: Genetic Systems Corp.
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1987-01-15
Decision date: 1987-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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