FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)— 510(k) K972720

Name: FDA 510(k) clearance K972720
Creator: U.S. Food and Drug Administration
Published: 1997-09-02

Substantially Equivalent

Monobind

FDA 510(k) clearance K972720 for FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300), Substantially Equivalent on 1997-09-02. Applicant: Monobind. Device class: 1.

Clearance details

Applicant: Monobind
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1997-07-21
Decision date: 1997-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.