FSH IRMA IMMUNOMAG— 510(k) K912804

Name: FDA 510(k) clearance K912804
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Pantex, Div. Bio-Analysis, Inc.

FDA 510(k) clearance K912804 for FSH IRMA IMMUNOMAG, Substantially Equivalent on 1991-08-12. Applicant: Pantex, Div. Bio-Analysis, Inc.. Device class: 1.

Clearance details

Applicant: Pantex, Div. Bio-Analysis, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1991-06-25
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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