BIODATA TESTOSTERONE MAIA KIT— 510(k) K955102

Name: FDA 510(k) clearance K955102
Creator: U.S. Food and Drug Administration
Published: 1996-06-24

Substantially Equivalent

Biochem Immunosystems (U.S.), Inc.

FDA 510(k) clearance K955102 for BIODATA TESTOSTERONE MAIA KIT, Substantially Equivalent on 1996-06-24. Applicant: Biochem Immunosystems (U.S.), Inc.. Device class: 1.

Clearance details

Applicant: Biochem Immunosystems (U.S.), Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1995-11-08
Decision date: 1996-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

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