IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)— 510(k) K885065

Name: FDA 510(k) clearance K885065
Creator: U.S. Food and Drug Administration
Published: 1989-01-04

Substantially Equivalent

3M Company

FDA 510(k) clearance K885065 for IGE FASTSCREEN S6 (F1, F2, F4, F13, F14), Substantially Equivalent on 1989-01-04. Applicant: 3M Company. Device class: 2.

Clearance details

Applicant: 3M Company
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1988-12-06
Decision date: 1989-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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