TRICHOMONAS DIRECT ENZYME IMMUNOASSAY— 510(k) K874259

Name: FDA 510(k) clearance K874259
Creator: U.S. Food and Drug Administration
Published: 1987-12-07

Substantially Equivalent

California Integrated Diagnostics, Inc.

FDA 510(k) clearance K874259 for TRICHOMONAS DIRECT ENZYME IMMUNOASSAY, Substantially Equivalent on 1987-12-07. Applicant: California Integrated Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: California Integrated Diagnostics, Inc.
Product code: Code JWZ
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1987-10-20
Decision date: 1987-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

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