PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT— 510(k) K890768

Name: FDA 510(k) clearance K890768
Creator: U.S. Food and Drug Administration
Published: 1989-03-21

Substantially Equivalent

Genetic Systems Corp.

FDA 510(k) clearance K890768 for PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT, Substantially Equivalent on 1989-03-21. Applicant: Genetic Systems Corp.. Device class: 2.

Clearance details

Applicant: Genetic Systems Corp.
Product code: Code LYF
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1989-02-15
Decision date: 1989-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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