MICRODILUTION IDENTIFICATION PANELS— 510(k) K864674

Name: FDA 510(k) clearance K864674
Creator: U.S. Food and Drug Administration
Published: 1987-01-05

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K864674 for MICRODILUTION IDENTIFICATION PANELS, Substantially Equivalent on 1987-01-05. Applicant: American Micro Scan. Device class: 1.

Clearance details

Applicant: American Micro Scan
Product code: Code JSE
Device class: Class 1
Regulation: 21 CFR 866.2320
Advisory panel: Microbiology
Date received: 1986-12-02
Decision date: 1987-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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K863776 — MICRODILUTION MIC PANELS1987-02-02
K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST1986-12-04
K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL1986-09-30

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