MODIFIED ELISA FOR CHLAMYDIA— 510(k) K896032

Name: FDA 510(k) clearance K896032
Creator: U.S. Food and Drug Administration
Published: 1990-01-29

Substantially Equivalent

Fairleigh Dickinson Laboratories, Inc.

FDA 510(k) clearance K896032 for MODIFIED ELISA FOR CHLAMYDIA, Substantially Equivalent on 1990-01-29. Applicant: Fairleigh Dickinson Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Fairleigh Dickinson Laboratories, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1989-10-16
Decision date: 1990-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abilene, TX, US

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