CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST— 510(k) K864389

Name: FDA 510(k) clearance K864389
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K864389 for CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST, Substantially Equivalent on 1986-12-04. Applicant: American Micro Scan. Device class: 1.

Clearance details

Applicant: American Micro Scan
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1986-11-06
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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