SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY— 510(k) K850787

Name: FDA 510(k) clearance K850787
Creator: U.S. Food and Drug Administration
Published: 1985-03-26

Substantially Equivalent

Nms Pharmaceuticals, Inc.

FDA 510(k) clearance K850787 for SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY, Substantially Equivalent on 1985-03-26. Applicant: Nms Pharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant: Nms Pharmaceuticals, Inc.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1985-02-26
Decision date: 1985-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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