FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY— 510(k) K884047

Name: FDA 510(k) clearance K884047
Creator: U.S. Food and Drug Administration
Published: 1989-03-14

Substantially Equivalent

Disease Detection International, Inc.

FDA 510(k) clearance K884047 for FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY, Substantially Equivalent on 1989-03-14. Applicant: Disease Detection International, Inc.. Device class: 2.

Clearance details

Applicant: Disease Detection International, Inc.
Product code: Code LYF
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1988-09-26
Decision date: 1989-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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