AUTOPAK ESTRIOL TEST DELIVERY SYSTEM— 510(k) K821678

Name: FDA 510(k) clearance K821678
Creator: U.S. Food and Drug Administration
Published: 1982-06-24

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K821678 for AUTOPAK ESTRIOL TEST DELIVERY SYSTEM, Substantially Equivalent on 1982-06-24. Applicant: Micromedic Systems. Device class: 1.

Clearance details

Applicant: Micromedic Systems
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1982-06-08
Decision date: 1982-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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