NORDICLAB TOTAL ESTRIOL RIA TEST— 510(k) K792189

Name: FDA 510(k) clearance K792189
Creator: U.S. Food and Drug Administration
Published: 1979-11-13

Substantially Equivalent

Nordiclab Intl.

FDA 510(k) clearance K792189 for NORDICLAB TOTAL ESTRIOL RIA TEST, Substantially Equivalent on 1979-11-13. Applicant: Nordiclab Intl.. Device class: 1.

Clearance details

Applicant: Nordiclab Intl.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1979-10-31
Decision date: 1979-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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