NEG COMBO BREAKPOINT PANEL POS COMBO— 510(k) K854278

Name: FDA 510(k) clearance K854278
Creator: U.S. Food and Drug Administration
Published: 1986-03-04

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K854278 for NEG COMBO BREAKPOINT PANEL POS COMBO, Substantially Equivalent on 1986-03-04. Applicant: American Micro Scan. Device class: 1.

Clearance details

Applicant: American Micro Scan
Product code: Code JWX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1985-10-24
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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